Regulatory Services Delivery Head

Celegence is looking for an experienced Delivery Head for Regulatory Services who can manage our fast-growing team in Bangalore, India.

Roles & Responsibilities

  • Set strategy for the BPaaS offering within Regulatory
  • Setup, expand and manage the services team that is to deliver different services
  • Define Operating and Delivery Model for BPaaS this should include but not limited to the list below:
    • Work with Quality Control team on different process areas related to service delivery
    • Adopt and improve existing service delivery process in the context of BPaaS
    • Define new processes for service delivery, setting up SLA and KPI for reach processes
    • Process areas to be considered – Quality Management, Communication, Governance, and Training and Continuous skill set improvement plan, Resource management, Data Security and Protection. Set strategy for the BPaaS offering within Regulatory
  • Implement Operating and Delivery Model, Quality Control Plan and Customer Data Protection processes
  • Review above mentioned deliverables with management and implement respective process areas
  • Report progress on regular basis Celegence management team with KPI details.
  • Build delivery team by supporting interview, on-board process including training for new resources
  • Responsible for managing delivery as per SLA in accordance with the SOW
  • Collaborate with other departments like Product Engineering, Product Management, Business Unit, etc. to improve service offerings and overall customer satisfaction
  • Support roadshows and industry events like DIA etc. to promote company’s solution and services.
  • Implement and practice company’s values.
  • Responsible for Service Delivery KPI and Goals for India delivery center
  • Understands and will abide by ISMS policy and processes of the company.
  • Support Sales and Marketing on Regulatory BPaaS and related services
  • Interact with customers and prospects to help promote regulatory services

Education & Experience

Education:

  • Bachelor Degree in Computer Science, Engineering or any relevant Life Sciences fields. Master’s Degree preferred.
  • PMP, RAC, ITIL certification is a plus.

Experience:

  • Minimum 8-10 years of relevant experience
  • Familiar with the Life Sciences Industry, preferably Regulatory
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Experience in managing Regulatory Affairs either as part services organization or life sciences company
  • Able to work independently
  • Able to travel up to 30% of time including to Europe and US
  • Fluent in English

Skills and Competencies

Technical Skill

  • Project Management

Non Technical Skills

  • Hands on person with a flair for Strategy formulation
  • Good knowledge of strategy development and implementation Techniques
  • Be a People Person & be able to weave into the Organization seamlessly
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem solving skills

Traits

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management
  • Strong Project management and tracking
  • Positive Attitude
  • Leadership Skill
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere

 

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