Global Biosimilars Project Manager
7 days ago
We aim to impact a billion lives at Biocon Biologics by fostering a culture of affordable innovation, patient centricity, and disruptive thinking. Our long-term commitment is to bring high-quality affordable biosimilars to patients all over the globe.
Job RoleThe Global Program Manager will oversee the drug registration, commercial launch, and life cycle management of the biosimilars portfolio in Emerging Markets. This role involves managing activities from regulatory strategy, dossier preparation, regulatory filings, query responses, regulatory approval, commercial launch, and post-approval changes, including capacity expansion.
Key Responsibilities- Oversee drug registration and commercial launch processes for biosimilars in Emerging Markets.
- Develop and execute regulatory strategies, dossier preparation, and regulatory submissions.
- Manage commercial launch and post-approval changes, including capacity expansion.
- Coordinate multiple projects, ensuring adherence to deadlines.
- B.Sc./B.Pharm/M.Sc./M.Pharm from an accredited university or college, or equivalent experience.
- MBA and/or PMP certification is desired.
- 8 to 15 years of relevant work experience.
- Prior experience in regulatory affairs is preferred.
- Experience working in Emerging Markets is highly desirable.
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