Director of Global Regulatory Sciences
5 days ago
About the Role
This is an exciting opportunity to join our team as a CMC Regulatory Associate Director, Small Molecule. In this role, you will be responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Small Molecule products.
Key Responsibilities
- Participate on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research.
- Independently provide strategic guidance/input related to current regulatory requirements and expectation for small molecule marketing applications, clinical trial applications for projects, and/or lifecycle changes to marketed products.
- Independently manage and prioritize multiple complex projects, including support of direct reports and their projects.
- May interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics.
- Identify, communicate and propose resolutions to routine/complex issues.
- Interpret global regulations and guidance. Identify regulatory opportunity and risks.
- Anticipate and communicate possible regulatory paradigm shifts.
- May support deviation investigations.
- Review and provide regulatory assessments on change controls.
- Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents.
- Manage relationships with diverse teams.
- Utilize electronic systems for dossier creation and tracking.
- Manage and actively support growth and development of any/all direct reports.
- Strong oral and written skills.
- Proficient with electronic systems.
- Prior management skills and/or experience preferred.
Qualifications & Experience
- Minimum BA/BS Degree
- 7-10+ years Pharmaceutical industry experience, including multi-disciplined experience, 6+ years CMC regulatory strategy.
- Knowledge of CMC regulatory requirements during development and post-approval and experience with global CMC regulations for biologic products.
- Knowledge of pharmaceutical development, including drug substance, drug product and analytical methods.
- Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
- Ability to identify, communicate and resolve complex issues.
- Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
Equal Employment Opportunity
Bristol Myers Squibb is an equal opportunity employer. We consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming patients' lives through science.
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' LivesBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. As a key member of our Global Regulatory Sciences team, you will play a critical role in ensuring the quality and compliance of our biologics products. This includes developing, compiling, maintaining, and...
-
Regulatory Sciences Director
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Regulatory Sciences Director to join our team.The CMC Regulatory Expert will be responsible for content development, compilation, maintenance, and review of the Quality...
-
Global Regulatory Sciences Director
6 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceAs a member of the Global Regulatory Sciences team at Bristol Myers Squibb, you will play a critical role in ensuring the quality and safety of our products. We are seeking a highly skilled and experienced Regulatory Sciences Expert for Small Molecule Products to join our team. ResponsibilitiesDevelop and implement...
-
Regulatory Sciences Associate Director
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director to join our team.The successful candidate will be responsible for content development, compilation,...
-
Regulatory Sciences Associate Director
1 week ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeDescriptionThe Global Regulatory Sciences organization at Bristol Myers Squibb provides regulatory expertise related to chemistry, manufacturing, and controls (CMC) activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in...
-
Regulatory Sciences Associate Director
1 week ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Regulatory Sciences Associate Director to join our team.The successful candidate will be responsible for developing and implementing regulatory strategies for our...
-
Regulatory Sciences Associate Director
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director to join our Global Regulatory Sciences team.Job SummaryThe Regulatory Sciences Associate Director will be...
-
Global Regulatory Sciences Lead
6 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceThe CMC Regulatory Associate Director, Biologics plays a pivotal role in developing, compiling, and reviewing the Quality Module for regulatory submissions related to biologics products, encompassing clinical trial applications, new marketing applications, HA responses, and background packages. As the primary...
-
Regulatory Sciences Associate Director, CMC
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Regulatory Sciences Associate Director, CMC to join our team.Job SummaryThe Regulatory Sciences Associate Director, CMC will be responsible for developing and...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeAbout the OpportunityBristol Myers Squibb is seeking a highly skilled Regulatory Sciences Director to lead our biologics development efforts. As a key member of our Global Regulatory Sciences team, you will be responsible for developing and implementing regulatory strategies to support the approval and commercialization of our biologics products.Key...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced CMC Regulatory Director, Small Molecule to join our team.Job SummaryThe CMC Regulatory Director, Small Molecule will be responsible for developing and...
-
Regulatory Sciences Associate Director
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director - CMC to join our team.Job SummaryThe CMC Regulatory Associate Director, Biologics will be responsible for content development,...
-
Regulatory Sciences Associate Director
3 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company that is dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Regulatory Sciences Associate Director to join our team.The successful candidate will be responsible for developing, compiling, and reviewing...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Global Regulatory Sciences team, focusing on CMC (Chemistry, Manufacturing, and Controls) for small molecule products.Key...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe Global Regulatory Sciences Cell Therapy Associate Director is responsible for developing and executing regulatory strategies for Cell Therapy products. This role requires expertise in global CMC regulatory requirements, cell therapy drug development processes, and analytical methods.Key ResponsibilitiesRepresent GRS-CMC on matrix teams for...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe Associate Director for Global Regulatory Sciences Cell Therapy is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding clinical trial applications, new marketing applications, Health Authority responses and background packages, and...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe Global Regulatory Sciences – Chemistry, Manufacturing and Controls (GRS-CMC) organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full timeTransforming Patients' Lives Through ScienceAt Bristol Myers Squibb, we're dedicated to creating innovative solutions that improve patients' lives. As a key member of our Global Regulatory Sciences team, you'll play a vital role in ensuring the quality and integrity of our biologics products.Key ResponsibilitiesDevelop and maintain regulatory strategies for...
-
CMC Regulatory Associate Director Biologics
6 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeWork with UsAt Bristol Myers Squibb, we're committed to transforming patients' lives through science. As a key member of our team, you'll play a vital role in shaping the future of healthcare. Our work is challenging, meaningful, and life-changing – and so is your career.The CMC Regulatory Associate Director, Biologics is responsible for content...
-
Cell Therapy Regulatory Sciences Director
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeJob SummaryThe Global Regulatory Sciences – Chemistry, Manufacturing and Controls (GRS-CMC) organization at Bristol Myers Squibb provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies...
