Manager Global Regulatory Affairs

2 weeks ago


Bengaluru, Karnataka, India Biocon Biologics Full time
Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, IN

BIOCON BIOLOGICSBiocon 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 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 in developed and emerging markets.


Job Summary:
Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.
Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolioCoordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar productsCollaboration with partners to develop and execute global regulatory activitiesPlan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirementsProvide regulatory direction on global regulatory requirements to support product developmentEnsure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycleSupport development and execution of clinical/non-clinical strategiesProvide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registrationCollaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plansWith minimal supervision, participate in development of risk management and contingency planningEnsure and lead regulatory compliance for biosimilar productsParticipation in regulatory meetings with Health Authorities

Knowledge and Skills:
Comprehensive understanding of Regulatory activitiesRegulatory experience with product filingsTeam skills, especially in working with internal and external partnersFamiliarity with project management requirementsAbility to understand and communicate scientific CMC informationAnticipate and prevent potential issuesAbility to communicate regulatory strategies and requirements to ensure expectations are understood

Education/Qualification:
B Pharm/M Pharm, B Tech/M Tech Biotech, BSc/MScA min of 5 years of experience in global regulatory affairsPreference for folks who has global RA experience in advanced markets

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