Medical and Regulatory Affairs
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The key objective of this role is to drive Regulatory department performance in order to deliver timely regulatory submissions (paper / electronic) and approvals, while promoting integrity, transparency and proactive communication of expectations to stakeholders, for regulatory activities like, but not restricted to
- New drugs/biologics, subsequent new drugs/biologics, new/additional dosage strengths/forms, manufacturing site, import license registration/renewal registration; withdrawals, etc. for commercialized products
- Post-approval variations/amendments like CMC, CCDS (i.e. package inserts) and labelling, manufacturing site, company registered address etc. for commercialized products
- Study protocol, protocol amendments, test license, investigation sites, periodic study reports etc. for clinical trials
- Health Authority commitments and queries
• Degree in Pharmacy or in other Life Sciences,
• 5-10 years of core functional regulatory knowledge an of which 3- 5 years of experience in leading the country regulatory team
• Exposure to international regulatory environment and capability to adapt the regulatory organization and implement appropriate plans.
• Proven experience and ability to manage people and cross functional groups
• Demonstrated track record of developing teams and creating working systems and processes
• Ability to negotiate
• Fluency in English
• Willingness to travel (approx.20% of working time, to Delhi)
Please note the posting is open up to 19/12/2019.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.