Home Regulatory Affairs Sr Executive | Regulatory Affairs | Pfizer India | Chennai, India

Sr Executive | Regulatory Affairs | Pfizer India | Chennai, India


Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and the potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group
Pfizerites are united by the knowledge that what they do really makes a difference in society — that they help people live longer, healthier, happier and more productive lives.

The global Pfizer leadership is making efforts to make the company lean and agile. Employees are encouraged to be innovative and entrepreneurial. We are also working to create an environment where all colleagues have the opportunity to grow and maximize their contributions to the company’s success.

Pfizer is a Fortune 500 company that embraces the spirit of a small company while exploiting the advantages of its unmatched scale and reach.

Position: Senior Executive, Regulatory Affairs

Location: Chennai, Tamil Nadu

Job Description:

  • Functions as Regulatory support for Biosimilars development projects and the lifecycle changes work with Global Product Owners (GPOs), cross-functional teams, local and regional regulatory colleagues, external partners (in case of in-licensed products) and  Global Health Authorities (US and Ex-US) to frame and drive global regulatory strategies and Global submissions.
  • Manages the preparation and maintenance of core dossiers for original applications and subsequent changes and coordinates responses to deficiency letters, with the assistance of local and regional regulatory colleagues.
  • Provides adequate support and guidance to the team for authoring regulatory submissions and ensures effective data presentation and quality.

  • The author with team members, key pieces of regulatory submissions on a need basis.
  • Advices Biosimilars programs on the regulatory requirements, coordinates and presents regulatory data needs, and negotiates with and influences management, cross-functional teams, and external partners to ensure regulatory data requirement and the deliverable dates are met.
  • Negotiates submission data requirements and deliverable dates with regulatory authorities on a need basis.
  • Remains knowledgeable and maintains awareness about current regulations and guidance related to Biosimilars, interprets, assesses its impact on product development programs, and communicates to necessary stakeholders.
  • Drives resolution of issues. Communicates issues, impact, and outcomes to global regulatory management and core team.
  • Responsible for effective coordination and collaboration with the regional regulatory leads to ensure key submission deliverables assigned to the regional group.
  • Responsible for ensuring compliance of the team to the submission standards, procedures, and policies framed by Global Regulatory Affairs.
  • Suggests supports and implements system improvements to ensure regulatory compliance, reduce cycle time, and create efficiency.

Qualification: B.Pharma, M.Pharma

Experience: Not Defined

Click Here to Apply Now

Click for More Regulatory Affair Jobs

Join Us for Regular Vacancy Updates on –

Join Our Telegram Group

Join Our Facebook Group


Please enter your comment!
Please enter your name here

Must Read

Area Business Manager | Koye Pharmaceuticals | All Over India

Koye was launched to seek, identify and introduce to the market, essential drugs in areas of Speciality Primary Care, Respiratory, Gynaecology, IVF, Diabetology, Metabolics...