Director Regulatory Affairs EU

Vor 4 Tagen

Frankfurt, Deutschland Biocon Biologics Vollzeit

About the company:

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization.


Job Description:


  • The ideal candidate for leading the EU regulatory affairs department should have strong European specific regulatory affairs background, excellent leadership capabilities and communication skills, negotiation & liaising with European Medicines Agency (EMA) and other National Competent Authorities (NCAs). This position brings together EU regulatory requirements to derive the global development strategy in partnering with GRL (Global Regulatory Lead).
  • A Doctoral/Master degree in life sciences, pharmacy or related field is required as well as experience in regulatory strategy, operations, labelling development, promotional material review and submissions in the biologics and biosimilar industry.


  • Minimum 12 years relevant experience out of which more than 5 years of people management
  • Responsible for EU regulatory strategy of both products approved and products under development.
  • Keep abreast of internal and external changes, trends, developments and other dynamics relevant to the regulatory environment that may have an impact on BBL products and business.
  • Will serve as the point of contact for the Agency’s interactions and act as local regulatory representative.
  • Supports development of European regulatory policies and generates policy positions.
  • Responsible to fulfil the module 1 requirements at local level such as Drug establishment licences, annual maintenance of DEL, test sites, NERBY submissions and supervision on pharmacovigilance.
  • Responsible for preparation, review and approval of module 1 sections in partnering with GRL and make them available for MAA submissions.
  • Assist Global Regulatory Head on product development strategy and participate in building the regulatory strategy.
  • Drive the EU product labelling and artwork with the GRL and labelling team to ensure core labels are appropriately complying with regional regulations.
  • Responsible for scientific advice, MAA and LCM submissions to EMA and NCAs incooperation with GRL and regulatory operations team.


Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.

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