Biosimilars Portfolio Manager

5 days ago


Bengaluru, Karnataka, India Biocon Biologics Full time

Transforming Healthcare with Innovative Solutions

Biocon Biologics is a leading biosimilars company that revolutionizes the healthcare industry with patient-centricity and affordable innovation.

We are committed to positively impacting a billion lives by fostering a culture of disruptive thinking, collaboration, and excellence.

As a multicultural global company, we offer a purpose-driven work environment where employees have the passion and autonomy to work closely with partners and patients.

We possess proven expertise in biosimilars, from development and manufacturing to clinical development, regulatory approvals, and commercialization.

About the Role:

The Global Program Manager will oversee 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.

The Program Manager will ensure these activities are executed effectively while meeting revenue targets linked to new registrations or commercial launches.

Key Responsibilities:
  • Oversee drug registration and commercial launch processes for biosimilars in Emerging Markets.
  • Ensure effective execution of regulatory strategies, dossier preparation, and regulatory submissions.
  • Manage commercial launch and post-approval changes, including capacity expansion.
  • Coordinate multiple projects, ensuring adherence to deadlines.
  • Meet revenue targets linked to new registrations or commercial launches.
  • Communicate and manage relationships with external partners to ensure alignment and successful project execution.
  • Facilitate collaboration between internal teams and external stakeholders.
Requirements:
  • B.Sc./B.Pharm/M.Sc./M.Pharm degree 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.
  • Strong analytical acumen and attention to detail.
  • Leadership skills and a proactive, go-getter attitude.
  • Advanced skills in MS Project and Excel.
  • Excellent communication and interpersonal skills for managing external partnerships.


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