At Celegence, you have the opportunity to shine and truly make a difference.
We have a growing organization where your inputs will be valued.
We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds.
Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment.
Project Delivery Management
Regulatory Affairs Data Management
Compliance Data Management
Regulatory Intelligence
Why Celegence?
Join us and be a part of a remarkable journey!
Here at Celegence, you get a great team that always stands by you, a supportive Manager who makes sure you are absolutely comfortable with the work you’re doing, an amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then), and most importantly, here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.
Employee Testimonials
Celegence is one of the most promising young companies in the industry. After more than two years working here, I can confidently say that it provides great opportunities to anyone in the organization looking to enhance their knowledge and skills. The culture has allowed me to grow my leadership and management skills, and it has also been motivating to have been part of the company’s growth since early on. Working at Celegence, a ‘typical day’ is never typical, there is always an interesting new challenge to navigate and every day is filled with learning opportunities. The company allows us to wear many hats, which keeps the workplace exciting and fast paced.
The aspect of Celegence that I have enjoyed most is the support system from Senior Management. They are open to new ideas and they always provide assistance for any obstacles that my team might be facing. I thoroughly enjoy working in such a collaborative atmosphere and am truly grateful to be a part of this organization.
I am happy to be a part of the Celegence family. It has been a great learning experience from Celegence so far and the friendly environment here helps me work enthusiastically every single day. Because of the teamwork and the support from the team members I was able to achieve “The Employee of Choice Award” in a short period of time. Definitely looking forward to learning more and growing along with Celegence’s family.
I started my professional career with Celegence. Right from the day of virtual on-boarding as a fresher in pandemic, till date, I feel Celegence is my [extended] family. With a positive work culture, teamwork, transparency, colleague support, and motivation from my seniors, I tend to grow each day. We celebrate each festival together. With work, we also focus on fun activities that relax us from our daily schedule. Celegence is growing every single day and so am I with Celegence. I recommend joining Celegence for people who really want to follow their passion and to get an amazing work experience. Thankful and obliged to Celegence for providing me with an excellent opportunity to excel in my career.This is my journey with Celegence!
What’s yours?
I have been working at Celegence for over a year. I have had the opportunity to work on challenging and complex projects in varied therapeutic areas that have further improved my skills as a medical writer. I am grateful to be working with a talented, diverse and supportive team that I can count on. I like that Celegence recognizes and appreciates the work and contribution the employees make towards the team and the organization. I am proud to be a part of Celegence that is making an impact in the healthcare sector via regulatory compliance.
I’m glad to gain experience in Celegence. This company allows you to wear multiple hats, empowers you with freedom to make decisions and has a great mix of all age groups to collaborate and create an inspiring work environment. I have a lot to be thankful to my Manager as they are behind this great learning experience. Right from my interview with my Manager and then later with the HR, I knew that Celegence is going to have a great enhancement in my learning. Not only is it a blessing to work with the team members and managers here, but it also gives me challenges that help me to hone my work and efforts. Also, I’m grateful to all my colleagues here who contributed to my journey so far. I’m definitely keen to cover many more years of this amazing learning.
Celegence is a great place to work. The culture is transparent, every employee, irrespective of their position is given a chance to be heard, and there are very good opportunities available to those who want to build a career here.
It is a young organization with an innovative and entrepreneurial approach that distinguishes it from its competitors. I have been with the organization for almost 3 years now and have seen myself transform as a professional in more than one way. In the meantime, I have gained valuable experience on most of the interesting digital marketing activities to which I have been assigned. I have the utmost respect for the company’s drive to continuously develop new technologies and improve working process and employee skills. I work very closely with our COO which has given me a valuable insight into a different culture and great level of learning.
Current Job Openings at Celegence
Finance Executive – US Bookkeeping
Employment Type: Full Time | Office Based | Bengaluru
Celegence is looking for a Finance Executive with 7+ years of relevant experience.
About the Company
Celegence LLC is a privately owned business based in Chicago, IL, USA, with offices in the UK, EU, and India. We provide clients with consulting services and solutions to support their regulatory affairs operations and strategy. Our fully trained resources support companies in their day-to-day operations by ensuring global regulatory compliance, leveraging their expert knowledge, and our technology and automation to improve compliance.
The vision of Celegence is to be the premier niche provider of regulatory services and solutions, to improve outcomes for the life sciences industry. Our primary objective is to provide end-to-end regulatory solutions enabling life science organizations to deliver exceptional patient value.
Roles & Responsibilities
- Establishing different accounts
- Maintaining records of financial transactions by posting and verifying
- Defining bookkeeping policies and procedures
- Developing systems to account for financial transactions by establishing a chart of accounts
- Maintaining subsidiary accounts by posting, verifying and allocating transactions
- Reconciling entries to balance subsidiary accounts
- Maintaining a balanced general ledger
- Preparing a trial balance for the accountants
- Preparing financial reports by collecting, analyzing and summarizing accounting for information
- Ensuring compliance with federal, state and local legal requirements
- Monitoring for variances from the projected budget
- Advising management on compliance needs
- Assisting in financial activities such as running payroll and generating invoices
- Implementing invoicing procedures
- Tracking, reviewing, approving, and issuing invoices
- Defining invoicing data types and maintaining databases
- Investigating slow approvals
- Managing client requests and queries
- Uploading and archiving invoice data, as well as filing contracts
- Verifying tax information
- Assisting with past due or denied invoices
- Customer follow ups – Collection Summary
- T&E Expense Reports
- Vendor Payments
Education & Experience
Education:
- Bachelor’s degree in accounting, finance or related discipline
- CPA is desirable
Experience:
- Previous bookkeeping experience preferred
- Experience working in a fast-paced environment
Skills
Technical Skills
- Basic accounting knowledge
- Knowledge of IFRS
- U.S. GAAP or other industry-standard accounting frameworks
- Expertise in Microsoft office
- Deep understanding of accounting principles
- Extensive experience in processing invoices
- Ability to review invoices and verify tax information
- Knowledge in QuickBooks online
Soft Skills
- Confidentiality
- Attention to detail
- Comfortable dealing with huge volumes of complex data
- Excellent organizational and communication skills
- Advanced ability to collaborate
- Manage client requests
- Answer queries
Competencies
- Person with 7+ yrs of experience with more than 5+ years in same field is preferred
Personal Traits
- Openness
- Conscientiousness
- Extraversion
- Agreeableness
Regulatory Affairs – SME
Employment Type: Full Time
Celegence is looking for a Regulatory Affairs SME with 5 – 7 years of relevant experience.
About the Company
Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.
Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.
Roles & Responsibilities
- Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
- Manage various activities in RIMS database under product life cycle management (Registration, Variation, Renewals and submission)
- Prioritize target activities and Produce high quality deliverables
- Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables
- Adherence to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables
- Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
- Assist and support internal audits performed by Client
- Support implementation of Regulatory Affairs systems as per Client or Partner projects
- Support peers and resolve issues related to project
- Develop and establish standard processes in collaboration with QA submission related checklists and template preparation (wherever applicable)
- Conduct quality control of performed regulatory work as part of the daily routine
- Set-up and maintain local SOP system describing all procedures and processes to ensure compliance and share with Client
- Effective usage of applicable RA electronic systems
- Accountable for resource utilization, management and competency development of the teams assigned with inclusion at Individual level role
- Understands and will abide by IQMS policy and processes of the company
- Lead/Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
- Ensure customer success throughout the engagement
- Drive end to end IDMP data preparation & readiness: data assessment at source, data remediation, data transformation, data enrichment and data completeness
Education & Experience
Education:
- Bachelor’s Degree in pharmacy or any relevant Life Sciences fields. Master’s Degree is preferred
- RAC certification is a plus
Experience:
- Minimum 5 – 7 years of relevant Regulatory Affairs experience required
- Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide and SPOR
- With good understanding of regulatory information management & associated business processes, provides expertise in managing IDMP data & processes in a global RIMS platform
- Skilled in Regulatory Information Management
- Business processes experience and good understanding of RIMS processes, Publishing, Labeling, CMC and Other Variations, Manufacturing and supply chain etc.
- Performed SME role in the past for implementation projects and regulatory affairs business process areas and training delivery experience is a plus
- Familiar with current knowledge of electronic document and submission requirements applicable to the EU, US, and global regulatory environments
- Participated in the implementation of new health authority guidelines and rules relevant to regulatory submissions
- Experience coordinating with artwork supply, artwork review and approval of artwork for labelling variations
- Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
- Working experience or understanding of external pharmaceutical data standards like pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.
- Knowledge of regulations, legislation, best practices and guidelines relating to RIMS or compliance initiatives. (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards etc.)
- Experience in customer interaction and ensure customer success throughout the engagement
- Able to work independently
Skills
Technical Skills
- Hands on experience related to Regulatory Processes including related IT systems
- Hands of experience on presentation tools like PowerPoint, Visio etc.
Non-Technical Skills
- Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
- Worked in the capacity of lead or senior role responsible for project or sub workstream in the past
Competencies
- Excellent Communication (Writing and Verbal)
- Customer Focused
- Organization Skills
- Drive to deliver superior quality proposals
- Strong Time management
- Good Stakeholder management
Personal Traits
- Positive Attitude
- Initiative and Commitment
- Leadership Skill
- Detailed Oriented
- Team player
- Focused and sincere
- Perseverance
Bookkeeper/Accounting Assistant – Chicago, IL
Employment Type: Full Time
Celegence is looking for a Bookkeeper/Accounting Assistant in Chicago, IL region with 5 or more years of bookkeeping and accounting experience.
About the Company
Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.
Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.
Roles & Responsibilities
- Reconcile the company’s bank statements and bookkeeping ledgers
- Prepare invoices for customers and manage payments collection process
- Keep track of upcoming monthly/quarterly/annually invoices for customers
- Receive and record bills and prepare report of upcoming payments
- Maintain and promote excellent vendor relations
- Complete analysis of employee expenditures
- Manage income and expenditure accounts
- Generate the company’s financial reports using income and expenditure data
- Monitor the company’s finances based on financial status
- Document transaction details
- Generate financial reports
- Fact-check accounting data
- Notify senior staff of any accounting errors
- Record financial transactions
- Prepare semi-monthly payroll and track payroll data
- Manage customer contracts and SOW timeframes, issue timely invoices, and review collection payments
Education & Experience
Education:
- Bachelor’s degree or higher in Finance & Accounting, or equivalent work experience
- QuickBooks Online Certification, preferred
Experience:
- 5 or more years of bookkeeping and accounting experience
Skills
Technical Skills
- In depth knowledge and experience with QuickBooks Online (QBO)
- Initiate and manage financial/accounting software used by the company, QBO and Excel required
- Accounts Receivable, Accounts Payable, G/L, Billing, Invoice Management, Payroll, etc.
Non-Technical Skills
- Strong knowledge of all Microsoft Office applications
- Excellent data entry skills, preferred
- Customer service skills
Competencies
- Strong written and verbal communication skills
- Ability to communicate complex data in a clear way
- Problem solving and complex thinking skills
- Ability to meet deadlines
- Works well under pressure and responds well to tight deadlines
- Ability to work in a team and on your own
- Experience using time management skills such as prioritizing, organizing, and tracking to manage meeting deadlines and multiple projects with varying completion dates
- Accomplish goals with little or no supervision, depending on self to complete objectives and determine when escalation of issues is necessary
Personal Traits
- Works with integrity and ethically
- Upholds organizational values
- Sincere, focused, and detail oriented
- Positive Attitude
- Ability to manage, motivate, and inspire people to embrace change
Medical Device Regulatory Consultant – Europe, UK, USA
Roles & Responsibilities
- Maintain, develop, and share your expertise and knowledge on a specific expert area and participate in MDR related forums to understand the latest trends as well as approach prospective clients
- Actively participate in client bid defense meetings for Medical Device prospective projects
- Provide advisory consulting services, proactively monitor regulations across regions to advise companies on new regulations
- Provide SME consulting in the areas of regulatory strategy, submissions and operations
- As a medical device expert, you will support to build (technical) documentation and design dossiers in support of CE marking, 510(k), or other approval procedures
- Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e. MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA, ANVISA, Heath Canada, MHLW/PMDA & TGA (MDSAP requirements)
- Lead MDR gap analysis projects and conduct analysis of existing systems, processes and departments in terms of new regulation.
- For MDR Gap Assessments you will perform the following: Work with stakeholders to identify required changes to compliance processes and updating associated process documentation including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas
- Implement improvements to technical files and other documents like Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER)
- Understand current compliance situation of medical device to international standards
- Suggest and support implementation of changes to organization’s risk management processes
- Develop device risk assessments with input from clinical and technical experts within the organizations
- Identify actions required to ensure compliance with ISO 13485, MDSAP and MDR
- Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-MDR
- Make updates to labelling, SOPs, work instructions and policy documents to ensure compliance with the client’s corporate SOPs
- Assist in the development/construction of Technical Files according to the new MDR & STED format with emphasis on developing following documentations:
- Essential Requirements Evaluation Report to Annex I of MDR & IVDR
- Risk Management Reports / Documentation to ISO 14971:2012
- Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV 2.7.1 Rev 4
- PMCF Planning Report development according to MDR & IVDR and/or MEDDEV
- Development of Vigilance Reporting strategies to MDR & IVDR and/or MEDDEV
- Support regulatory submission projects with submission requirements for appropriate market and product type
- Establish and maintain a professional and credible relationship with direct clients (customer of Celegence) and indirect clients like Health Authorities, Notified Bodies and other regulatory agencies
- Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project time lines
- In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required
- Proactively follow the news and trends in the market to share with the rest of the team
- You may be asked to support marketing activities, such as webinars, blog writing, as well as business development activities such as presales meetings with prospective clients
- Supporting internal and external audits as required
- Provide status reporting to stakeholders according to an agreed communications plan
Education & Experience
Education:
- Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
- RAC certification: Medical Devices is a plus
Experience:
- Minimum 5 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality or regulatory roles
- Experience writing MDR compliant Clinical Evaluation Reports and other documents
- Knowledge of Quality Management Systems implementation to ISO 13485:2016
- Knowledge of Risk Management Systems based on ISO 14971:2012
- Experience in creating customer facing materials and conducting workshops as SME
- Knowledge of Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada
- Worked in a client-focused organization as a consultant in the past
- Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices
- Fluent in English
Skills and Competencies
Technical / Functional Skills:
- Excellent knowledge of MDD/MDR
- Excellent knowledge of ISO 13485 standards
- Good understanding of IMDRF requirements for member countries
- Strong stakeholder management experience
Non-Technical Skills:
- Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
- Good knowledge of strategy development and implementation techniques for Medical Device registrations, compliance towards new regulations etc.
- Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
Competencies:
- Excellent Communication (Writing and Verbal)
- Customer Focused
- Organization Skills
- Strong Time management
- Good Stakeholder management
- Project management and tracking
Personal Traits:
- Positive Attitude
- Initiative and Commitment
- Leadership Skills
- Detailed Oriented
- Team player
- Focused and sincere
- Perseverance
Competitive Compensation & Benefits
Supportive Work Environment
Growth Opportunities
Join Our Team
If you are interested in joining our team, please fill out the form below or email careers@celegence.com and we will contact you for further discussion.