Job Description: Director, RA CMC Biologics & Rare Diseases
Location: Bangalore, India
Job Category: Reg Affairs & Safety Pharmacovigilance
Novo Nordisk is a global healthcare leader with a century-long commitment to changing lives through innovative solutions. Building on our legacy in diabetes care, we are expanding our reach to millions of patients globally, impacting over 40 million lives daily. Join us in shaping the future of healthcare and making a tangible difference.
Novo Nordisk is seeking an experienced pharmaceutical leader to join as Director of RA CMC Biologics & Rare Diseases. The successful candidate will lead a dynamic team within the rapidly growing RA CMC Life Cycle Management organization, overseeing regulatory activities for biologics and rare diseases. As Director, you will be responsible for driving strategic initiatives, ensuring compliance, and fostering collaboration across various departments.
Leadership: Lead and develop a team of over 30 specialists, ensuring alignment with Novo Nordisk’s values and goals. Drive people processes, employee development, and resource utilization.
Regulatory Strategy: Oversee the regulatory CMC development activities for biologics and rare diseases within Novo Nordisk’s pipeline, as well as early life cycle management for marketed products.
Collaboration & Stakeholder Management: Establish and maintain relationships with health authorities, agencies, vendors, and consultants. Drive communication both internally and externally, ensuring timely and effective interaction with key stakeholders.
Performance & Compliance: Ensure optimal performance, quality, and compliance within the department, fostering an environment of continuous improvement.
Education: Master’s degree with a minimum of 8 years of relevant experience, including 5+ years in leadership roles.
Experience: Demonstrated track record in global leadership, preferably within regulatory affairs and CMC life cycle management for biologics and rare diseases.
Skills:
At Novo Nordisk, we are united by our commitment to patients, innovation, and excellence. We believe that diverse perspectives are key to achieving breakthroughs in healthcare. With a team of over 63,000 employees, we create a collective effort that propels us toward our vision. Together, we’re life-changing.
Submit your application by uploading your CV online via the Apply Now button.
Please apply by 10th January 2025.
Disclaimer:
Beware of fraudulent job offers impersonating Novo Nordisk. We do not solicit personal information or fees from candidates as part of the recruitment process.
Novo Nordisk is an equal opportunity employer. We celebrate diversity and foster an inclusive culture where everyone can thrive.
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