career

Qualifications

• Bachelor’s Degree / Post Graduation in any relevant Life Sciences field.
• Master’s Degree is preferred.

Experience

• Minimum 2 years of experience in Medical Device Regulatory documentation.
• Publication experience in scientific journals is preferable.
• Familiarity with the Life Sciences Industry, preferably Regulatory Services.
• Hands-on experience on CEP/CER/PMSR/PSUR process.
• Experience in creating high-quality deliverables for customers.
• Experience in handling projects independently with minimal guidance.

Technical Skills

• Knowledge of clinical evaluation and related documents and regulatory requirements.
• Proficiency in comprehension of scientific data and medical terminology, and efficiency in summarizing information from source documents and published literature.
• Proficiency with Microsoft Office (Word, Excel, and Outlook).
• Hands-on experience with presentation tools (PowerPoint, Visio, etc.) and referencing tools (Zotero, Endnote, etc.) is an added advantage.
• Effective reviewing skills for review of work done by trainees/junior writers.

Soft Skills / Non-Technical Skills

• Strong verbal and written communication skills.
• Ability to work as part of a team.
• A constant zeal towards learning and skill development.
• Potential to multitask and work within timelines.
• Ability to understand and deliver on customer requirements.
• Potential leadership and mentoring skills.

Competencies

• Basic English grammar, punctuation, and sentence construction.
• Logical comprehension.
• Knowledge of medical terminology.
• Excellent Communication (Writing and Verbal).
• Quality-focused mindset.
• Good time management.

Personal Traits

• Positive Attitude.
• Initiative and Commitment.
• Detail-Oriented.
• Team player.
• Focused and sincere.
• Ownership and accountability of work.

Roles & Responsibilities

1. Perform literature searches on various databases.
2. Screening, appraisal per pre-defined criteria, and summarization of articles.
3. Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use.
4. Summarize quantitative data from post-marketing surveillance.
5. Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas.
6. Work with senior writers to prepare documents that meet client expectations in terms of language, content, format, and presentation.
7. Conduct proofreading, document formatting, incorporate comments from reviewers, and other document completion/approval activities.
8. Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
9. Train and mentor junior members of the team on technical/process-related aspects.
10. Conduct proofreading, editing, document formatting, review comment incorporation, and document completion/approval activities.

Qualifications

• Bachelor’s Degree / Post Graduation in any relevant Life Sciences field.
• Master’s Degree is preferred.

Experience

• Minimum 5+ years of experience in Medical Device Regulatory documentation.
• Publication experience in scientific journals is preferable.
• Familiarity with the Life Sciences Industry, preferably Regulatory Services.
• Hands-on experience on CEP/CER/PMSR/PSUR process.
• Experience in creating high-quality deliverables for customers.
• Experience in handling projects and engaging with multiple clients independently.
• Experience of working on projects involving all devices classes from various Therapeutic Areas.

Technical Skills

• Knowledge of clinical evaluation and related documents and regulatory requirements.
• Proficiency in comprehension of scientific data and medical terminology, and efficiency in summarizing information from source documents and published literature.
• Proficiency with Microsoft Office (Word, Excel, and Outlook).
• Hands-on experience with presentation tools (PowerPoint, Visio, etc.) and referencing tools (Zotero, Endnote, etc.) is an added advantage.
• Effective reviewing skills for review of work done by trainees/junior writers.

Soft Skills / Non-Technical Skills

• Strong verbal and written communication skills.
• Ability to work as part of a team.
• A constant zeal towards learning and skill development.
• Potential to multitask and work within timelines.
• Ability to understand and deliver on customer requirements.
• Mentoring skills to act as trainer/mentor for junior members of the team.

Competencies

• Basic English grammar, punctuation, and sentence construction.
• Logical comprehension.
• Knowledge of medical terminology.
• Excellent Communication (Writing and Verbal).
• Quality-focused mindset.
• Good time management.
• Good stakeholder management.

Personal Traits

• Positive Attitude.
• Initiative and Commitment.
• Detail-Oriented.
• Team player.
• Focused and sincere.
• Ownership and accountability of work.

Roles & Responsibilities

1. Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas.
2. Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.
3. Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation.
4. Assist the Team Lead/Manager in the development of schedules to ensure timely delivery.
5. Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables.
6. Train and mentor junior members of the team on technical/process-related aspects.
7. Conduct proofreading, editing, document formatting, review comment incorporation, and document completion/approval activities.
8. Perform literature searches on various databases.
9. Screening, appraisal per pre-defined criteria, and summarization of articles.
10. Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use.
11. Summarize quantitative data from post-marketing surveillance.
12. Conduct editing, proofreading, document formatting, and other document completion/approval activities.

Qualifications

• Bachelor’s degree in pharmacy, Regulatory Affairs, or a relevant Life Sciences field.
• Master’s degree preferred.
• RAC certification is a plus.

Experience

• Minimum 3–4 years of relevant Regulatory Affairs experience.
• Familiarity with the Life Sciences industry, preferably within Regulatory Affairs.
• Understanding of global regulations related to pharmaceuticals, medical devices, and biologics in the context of regulatory service offerings.
• Experience in creating customer-facing materials.
• Ability to work independently.
• Fluency in English.

Technical Skills

• Hands-on experience with regulatory processes and related IT systems.
• Experience with document-level publishing and submission-level publishing.
• Familiarity with Regulatory Information Management Systems (RIMS), Document/Content Management Systems, and eCTD submissions.

Soft Skills

• Strong verbal and written communication skills.
• Strategic thinking and problem-solving abilities.
• Ability to effectively influence and collaborate with others.

Competencies

• Strong written and verbal communication.
• Customer-focused approach.
• Drive to deliver high-quality work.
• Strong time-management and prioritization skills.

Personal Traits

• Positive attitude.
• Initiative and commitment.
• Detail-oriented.
• Team player.
• Focused and sincere.
• Perseverance.

Roles & Responsibilities

1. Serve as a member of the Centre of Excellence team responsible for the lifecycle management of assigned products.
2. Document-Level Publishing
   • Author and publish technical regulatory documents based on client product requirements.
3. Submission-Level Publishing
   • Compile dossiers in the required format for submission to relevant regulatory agencies.
4. Use and update Regulatory Affairs systems, including Regulatory Information Management Systems (RIMS), Document/Content Management Systems, and eCTD submission systems.
5. Manage activities across the product lifecycle, including registrations, variations, renewals, and submissions.
6. Prioritize assigned activities and consistently produce high-quality deliverables.
7. Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key deliverables.
8. Adhere to applicable regulatory guidelines, departmental SOPs, and client SOPs when preparing and delivering work.
9. Complete training provided by clients as well as required self-training and maintain appropriate training certificates and records.
10. Assist and support internal audits performed by clients.
11. Support the implementation of Regulatory Affairs systems for client or partner projects.
12. Understand and comply with the company’s Information Security Management System (ISMS) policies and processes.

About Celegence

Celegence LLC is a privately owned consulting organization headquartered in Chicago, Illinois (USA), with offices across the UK, Europe and India. The company specializes in Regulatory Affairs consulting services and technology solutions for the global Life Sciences industry.

Our experienced professionals support organizations in managing day-to-day regulatory operations by ensuring global compliance, applying deep industry expertise and leveraging technology and automation to improve operational efficiency.

Our vision is to become the premier niche provider of regulatory services and innovative solutions, enabling life science organizations to deliver exceptional patient value through end-to-end regulatory excellence.

Job Requirement

Technical Skills

• ISO 9001:2015 Standards
• QMS Document Management
• Audit Management
• Change Management
• CAPA Management
• Vendor Management

Soft Skills

• Strong communication skills (verbal and written)
• Analytical thinking and problem-solving ability
• Effective stakeholder collaboration and teamwork
• Time management with the ability to handle multiple priorities

Competencies

• Strong knowledge of ISO 9001:2015 standards and Quality Management System (QMS) processes.
• Audit Management including planning, execution and closure.
• Corrective and Preventive Action (CAPA) Management.
• Document Control and Change Management within the Quality Management System.

Personal Traits

Roles & Responsibilities

1. Document Control & Management
   • Maintain and update QMS documents including creation, review and revision in line with ISO standards.
   • Manage complete document lifecycle including version control and archival.
   • Review SOPs, Policies, Manuals and Work Instructions for accuracy and compliance.
   • Ensure periodic review and timely revision of documents.
   • Prepare and publish quarterly QMS reports with key metrics and insights.
2. Audit & Compliance
   • Schedule and coordinate internal audits as per the approved audit plan.
   • Conduct internal audits and document findings.
   • Share audit outcomes with Project Managers and Delivery Heads.
   • Support external audit preparation and readiness activities.
   • Track and ensure timely closure of audit findings.
3. Project Management Support
   • Maintain and update the Global Project Tracker.
   • Ensure project documentation remains complete and audit ready.
   • Verify project-specific risk assessments.
   • Track mitigation and contingency plans.
   • Support adherence to customer-specific QMS requirements.
4. Change Management
   • Coordinate with Cross Functional Teams to manage Change Requests.
   • Track Change Request lifecycle and closure.
   • Review Change Requests for completeness, risk and impact assessment.
   • Ensure proper risk analysis before approvals.
5. Vendor & Risk Management
   • Maintain and update the Approved Vendor List.
   • Ensure vendor documentation is complete and available.
   • Track vendor evaluation and re-evaluation activities.
   • Maintain department risk assessment trackers.
   • Support mitigation and contingency planning.
6. CFT Support & Training
   • Ensure adherence to QMS processes across functions.
   • Track action items and follow up for timely closure.
   • Conduct monthly QA discussions with functional teams.
   • Provide QMS training and awareness sessions.
   • Promote collaboration between QA and Cross Functional Teams.
7. Continuous Improvement & Innovation
   • Drive adoption of QMS tools and workflow automation.
   • Reduce manual dependency and improve data accuracy.
   • Track quality, efficiency and compliance improvement metrics.
   • Identify process improvement opportunities.
   • Promote continuous improvement and operational excellence.
   • Improve document control efficiency and traceability using automation tools.

About Celegence

Celegence LLC is a privately owned consulting organization headquartered in Chicago, Illinois (USA), with offices across the UK, Europe and India. The company delivers regulatory affairs consulting services and technology solutions to the global Life Sciences industry.

Our experienced professionals support customers in their day-to-day regulatory operations by ensuring global compliance, applying deep scientific expertise and leveraging technology and automation to improve operational efficiency.

Our vision is to become the premier niche provider of regulatory services and innovative technology solutions, enabling life science organizations to deliver exceptional patient value through end-to-end regulatory excellence.

Job Requirement

Technical Skills

• Deep knowledge of ICH M4Q guidelines, specifically Module 3 (3.2.S Drug Substance and 3.2.P Drug Product) requirements.
• Hands-on experience with authoring CMC sections for IND, NDA, MAA and lifecycle management activities.
• Global Health Authority regulatory compliance including US FDA, EMA and MHRA.
• Understanding of AI regulatory landscape across the US FDA and Europe.
• Hands-on experience with CARA, Veeva and D2 eDMS platforms including document creation, workflows and content planning.

Soft Skills

• Exceptional verbal, written and technical communication skills.
• Excellent stakeholder management skills across engineering teams, service delivery groups and pharmaceutical clients.
• Strong negotiation and conflict-resolution abilities to manage regional lifecycle timelines.

Personal Traits

Roles & Responsibilities

1. Regulatory Subject Matter Expert
   • Serve as the primary Regulatory Subject Matter Expert (SME) for the AI software development workstream.
   • Drive business requirements, particularly for Module 3 CMC content, ensuring the platform meets pharma readiness and operational delivery standards.
2. AI Platform & Document Authoring
   • Leverage AI platform capabilities to streamline regulatory document creation.
   • Integrate reviewer feedback while maintaining consistency, clarity and compliance throughout document authoring.
3. Process & SOP Development
   • Define cross-functional business processes and Standard Operating Procedures (SOPs).
   • Develop training modules to harmonize regulatory services with technology deployment.
4. Project Planning & Reporting
   • Manage project timelines and estimate effort for strategic initiatives.
   • Prepare projections, utilization reports and progress updates for leadership review.
5. Client-Focused Regulatory Solutions
   • Deliver highly customized regulatory solutions aligned with client requirements.
   • Ensure documentation meets regional expectations for language, content, formatting and presentation.