Global Regulatory Affairs - Europe

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 are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

About the Role:

The European Regulatory Affairs Role plays a pivotal role at Biocon Biologics in leading the regulatory affairs department. For this role, strong knowledge in European regulatory affairs, exceptional leadership capabilities, and effective communication skills for negotiation and liaising with the European Medicines Agency (EMA) and other National Competent Authorities (NCAs) are required. This position aligns EU regulatory requirements with global development strategies in collaboration with the Global Regulatory Head and Global Regulatory Leads (GRLs).

Key Responsibilities:

• Responsible for EU regulatory strategy for both approved products and those under development.
• Stay informed about internal and external changes, trends, developments, and other dynamics impacting Biocon Biologics products and business.
• Serve as the primary point of contact for NCA and EMA interactions and act as the local regulatory representative.
• Cooperate with other departments and affiliates within Biocon Biologics, partner, and regulatory consultants.
• Monitor and shape evolving regulatory landscape, support the development of European regulatory policies and generate policy positions.
• Prepare, review, and approve Module 1 sections in collaboration with the GRL to facilitate MAA submissions.
• Assist the Global Regulatory Head in developing product development strategies and participate in building the regulatory strategy.
• Drive EU product labelling and artwork in conjunction with the GRL and labelling team to ensure core labels comply with regional regulations.
• Responsible for scientific advice, MAA, and LCM submissions to EMA and NCAs in cooperation with the GRL and regulatory operations team.
• Attend cross functional projects where RA expertise is concerned (i.e., due diligence, etc.).

Key Requirements:

• A Doctoral or master’s degree in life sciences, pharmacy, or a related field is required, along with extensive experience in regulatory strategy, operations, labelling development, promotional material review, and submissions within the biologics and biosimilar industry.
• Minimum of 12 years of relevant experience, including more than 5 years in people management roles.