Sun Pharmaceutical Industries Limited is extending an invitation to individuals interested in joining India’s premier pharmaceutical company. We are seeking candidates for the Manager 1 position in Global Regulatory Affairs.
Job Description
- Strategic Regulatory Support: Provide CMC (Chemistry, Manufacturing, and Controls) strategy for drug substance and product throughout different clinical phases.
- Regulatory Compliance: Responsible for product registration, approval, and regulatory compliance across the product life cycle.
- Document Management: Review CMC documents, ensure quality submissions, and maintain the CMC Regulatory Affairs database up to date.
Key Responsibilities
- Strategy Development: Contribute to developing and executing regulatory CMC strategies for supported programs.
- Authoring Documents: Prepare CMC sections for submission packages (IND/IMPD/NDA/MAA) and manage their life cycle.
- Meeting Requests: Author CMC sections for meeting requests and briefing packages for scientific advice meetings.
- Gap Assessment: Identify CMC gaps, develop mitigation plans, and ensure implementation.
- Communication: Facilitate communication with regulatory agencies, health authorities, consultants, and internal stakeholders for CMC-related aspects.
- Program Participation: Participate in various stage gate meetings for assigned programs.
- Timeline Management: Set and monitor submission timelines with key stakeholders.
- Training: Conduct departmental and cross-functional level trainings as necessary.
- Regulatory Knowledge: Maintain updated knowledge of clinical phases and CMC requirements, as well as regulatory agency regulations, directives, guidelines, and policies.
Candidate Profile
- Education: M.Pharm/MSc
- Experience: 5-8 years in regulatory-related roles, preferably with experience in US/EU submissions.
- Skills: Understanding of R&D processes, technology transfer, and CMC topics for API and drug product. Knowledge of sterile and solid oral dosage forms desired. Strong prioritization and communication skills.
Additional Information
- Experience: 5-8 years
- Qualification: M.Pharm/MSc
- Location: Mumbai
- Industry Type: Pharma/Healthcare/Clinical Research
- Functional Area: Global Regulatory Affairs
- End Date: 31st March 2024
If you meet the qualifications and are interested in this opportunity, please apply before the specified end date. Join us in our mission to balance employment opportunities with delivering essential medications to the world.
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