Pfizer is hiring for the position of Associate II, Reg CMC Strategy in Chennai, India. The role focuses on Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for commercial pharmaceutical products, including global regulatory submissions, post-approval changes, and compliance activities.
The selected candidate will support global CMC regulatory planning, assess regulatory risks, and coordinate strategic activities with cross-functional project teams.
Job Details
| Particulars | Details |
|---|---|
| Company | Pfizer |
| Job Title | Associate II, Reg CMC Strategy |
| Job Requisition ID | 4966490 |
| Job Category | Regulatory Affairs |
| Location | Chennai, India |
| Job Type | Full-time |
| Work Model | Hybrid |
| Posting Status | Posted today |
| Application Mode | Online |
Position
Associate II, Reg CMC Strategy
This position is responsible for managing assigned CMC regulatory activities for commercial pharmaceutical products, with a focus on post-approval regulatory strategy, documentation, submissions, and compliance.
Key Responsibilities
- Develop and drive global CMC regulatory strategies for assigned products and projects.
- Prepare CMC documentation for submissions to global regulatory agencies.
- Manage post-approval changes and regulatory compliance activities.
- Assess regulatory risks and develop contingency and mitigation plans.
- Represent CMC within cross-functional project teams.
- Interpret regulatory requirements and guidelines and assess their global implications.
- Coordinate daily regulatory and strategic activities for assigned CMC products.
- Support interactions with internal partners and resolve regulatory issues within project teams.
- Make decisions on moderate issues in standard situations and escalate complex risks to leadership.
- Maintain compliance with company training, policies, and individual development plans.
- Participate in cross-disciplinary forums and learning opportunities.
- Use Pfizer’s CMC systems, including GDMS, PDM, SPA, and Rosetta, as appropriate.
Required Skills and Expertise
The responsibilities outlined in the job description involve the following areas of expertise:
- CMC regulatory strategy and documentation
- Global regulatory submissions
- Post-approval change management
- Pharmaceutical regulatory compliance
- Regulatory risk assessment and mitigation planning
- Interpretation of regulatory regulations and guidelines
- Cross-functional project coordination
- Regulatory issue resolution and escalation
- CMC systems and documentation management
Application Details
Location: Chennai, India
Work Arrangement: Hybrid
Employment Type: Full-time
