Senior Manager, Regulatory Operations
Bristol Myers Squibb
4 hours ago
Remote friendly (New Brunswick, NJ)
United States
Operations
Key Responsibilities
- Work as part of a team handling global market registrations and providing regulatory guidance, direction, and support to all External Manufacturing (EXM) groups.
- Support regulatory activities for new products and technology transfers, including strategy/timeline development, specification setting, and testing standard updates.
- Maintain strong communication and working relationships with departments, contract manufacturing organizations, and global regulatory/testing/compendial organizations.
- Coordinate External Manufacturing (EXM) dossier review and approval management for Module 2 and 3; prepare registration documents as required.
- Coordinate and review regulatory renewals, GMP renewals, and annual report submissions.
- Ensure appropriate documentation is maintained to support compliance of product manufacture at contract manufacturing organizations with regulatory filings.
- Participate in QA supporting activities as required (e.g., internal audits, site regulatory inspections, Annual Product Quality Reviews (APQR), quality risk management).
- Lead, motivate, mentor, and coach team members; provide performance feedback and developmental opportunities to meet department and company goals; drive continuous improvement.
Qualifications & Experience
- Minimum BSc in chemistry or related disciplines.
- Knowledge and operational experience in a GMP environment.
- Knowledge of CTD (Common Technical Document) structure, content, and requirements.
- Sound experience with regulatory processes and Health Authority requirements/guidance for FDA, EU, and global markets.
- Pharmaceutical experience with RSM, intermediates, API, and DP; or biologics DS and DP preferred.
- Strong knowledge of compliance requirements.
- Project Management skills desired.
- Strong technical knowledge of the regulatory landscape; ability to translate regulatory requirements into action.
Required Competencies
- Ability to work independently and within team matrix environments.
- Ability to manage teams tied to responsibility areas, including people management and project management.
- Thorough knowledge of worldwide regulatory GMP requirements; working knowledge of FDA and EU GMP requirements.
- In-depth knowledge of Quality Management Systems, change control principles, and applicability of restrictions for changes requiring health authority approval.
- Ability to objectively critique dossier content and health authority query/response content to maintain compliance.
- Ability to prioritize, organize, and manage multiple tasks to tight deadlines.
- Ability to balance business implications, technical considerations, and quality decisions.
- People Management: set objectives, coach, and prioritize team members’ work.
Compensation / Benefits (as stated)
- New Brunswick - NJ - US $125,340 - $151,884.
- Benefits include health coverage, wellbeing support programs, and financial protection (e.g., 401(k), disability, life insurance). Work-life benefits include Paid Time Off (including flexible time off/vacation and paid holidays, with additional eligibility-based time off).
- Work as part of a team handling global market registrations and providing regulatory guidance, direction, and support to all External Manufacturing (EXM) groups.
- Support regulatory activities for new products and technology transfers, including strategy/timeline development, specification setting, and testing standard updates.
- Maintain strong communication and working relationships with departments, contract manufacturing organizations, and global regulatory/testing/compendial organizations.
- Coordinate External Manufacturing (EXM) dossier review and approval management for Module 2 and 3; prepare registration documents as required.
- Coordinate and review regulatory renewals, GMP renewals, and annual report submissions.
- Ensure appropriate documentation is maintained to support compliance of product manufacture at contract manufacturing organizations with regulatory filings.
- Participate in QA supporting activities as required (e.g., internal audits, site regulatory inspections, Annual Product Quality Reviews (APQR), quality risk management).
- Lead, motivate, mentor, and coach team members; provide performance feedback and developmental opportunities to meet department and company goals; drive continuous improvement.
Qualifications & Experience
- Minimum BSc in chemistry or related disciplines.
- Knowledge and operational experience in a GMP environment.
- Knowledge of CTD (Common Technical Document) structure, content, and requirements.
- Sound experience with regulatory processes and Health Authority requirements/guidance for FDA, EU, and global markets.
- Pharmaceutical experience with RSM, intermediates, API, and DP; or biologics DS and DP preferred.
- Strong knowledge of compliance requirements.
- Project Management skills desired.
- Strong technical knowledge of the regulatory landscape; ability to translate regulatory requirements into action.
Required Competencies
- Ability to work independently and within team matrix environments.
- Ability to manage teams tied to responsibility areas, including people management and project management.
- Thorough knowledge of worldwide regulatory GMP requirements; working knowledge of FDA and EU GMP requirements.
- In-depth knowledge of Quality Management Systems, change control principles, and applicability of restrictions for changes requiring health authority approval.
- Ability to objectively critique dossier content and health authority query/response content to maintain compliance.
- Ability to prioritize, organize, and manage multiple tasks to tight deadlines.
- Ability to balance business implications, technical considerations, and quality decisions.
- People Management: set objectives, coach, and prioritize team members’ work.
Compensation / Benefits (as stated)
- New Brunswick - NJ - US $125,340 - $151,884.
- Benefits include health coverage, wellbeing support programs, and financial protection (e.g., 401(k), disability, life insurance). Work-life benefits include Paid Time Off (including flexible time off/vacation and paid holidays, with additional eligibility-based time off).