Global Program Manager

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 development, drug registration, commercial launch, and life cycle management of the biosimilars portfolio. This role involves managing activities from development, clinical and 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 approved schedule and cost baseline. The role can require 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 development and registration and commercial launch processes for biosimilars.
• Ensure effective execution of CMC, clinical and 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 approved schedule and cost baseline.
• 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.
• 5 to 12 years of relevant work experience.
• Prior experience in project/ progeam management is preferred.
• Strong analytical acumen and attention to detail.
• Leadership skills and a proactive, go-getter attitude.
• Advanced skills in MS Project and Excel.