Global Program Manager

2 weeks ago

Bengaluru, Karnataka, India Biocon Biologics Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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 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. The Program Manager will ensure these activities are executed effectively while meeting revenue targets linked to new registrations or commercial launches. The role requires handling multiple projects simultaneously and ensuring strict deadlines are met. The ideal candidate will possess strong analytical skills, a go-getter attitude, leadership abilities, attention to detail, and advanced proficiency in MS Project and Excel.

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 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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