Regulatory Affairs Intern – Global Regulatory Sciences
Location: Chennai, India (Hybrid)
Job Type: Full-Time
Job ID: 4949392
About the Role
Pfizer is dedicated to discovering breakthroughs that transform patient lives worldwide. As a Regulatory Affairs Intern within the Global Regulatory Sciences (GRS) team, you will gain hands-on experience in CMC (Chemistry, Manufacturing, and Controls) regulatory submissions while supporting cross-functional teams. This internship provides an opportunity to develop a deep understanding of global regulatory standards, compliance procedures, and pharmaceutical industry practices.
Key Responsibilities
Assist the CMC Global Regulatory Strategist (GRS-CMC) in day-to-day regulatory activities under guidance from the Team Lead.
Support the preparation, compilation, and submission of CMC packages in accordance with defined timelines.
Update impacted dossier components and ensure timely escalation of delays or risks to the CMC leadership.
Coordinate internal document review, approvals, and sign-offs while maintaining compliance with Pfizer internal procedures and SOPs.
Utilize Pfizer’s CMC systems, including GDMS, PDM, and SPA, for document management and submission tracking.
Contribute to process improvements within the team and share learnings with peers to enhance workflow efficiency.
Maintain accountability for professional development, prioritize tasks, and deliver high-quality results.
Required Qualifications
Postgraduate degree in Pharmacy or Life Sciences.
Strong attention to detail and organizational skills.
Excellent interpersonal and communication abilities.
Preferred Qualifications
Basic knowledge of regulatory requirements for post-approval changes.
Familiarity with pharmaceutical manufacturing standards, industry processes, and policies.
Understanding of the pharma industry environment and scientific research practices.
Work Environment
Hybrid work model (Chennai Office)
40 hours per week
On-premise assignments as required
Why Join Pfizer
Gain hands-on experience in global regulatory affairs and CMC submissions.
Work closely with experienced professionals across cross-functional teams.
Develop skills critical for a successful career in regulatory sciences, pharmaceutical compliance, and clinical research.
Be part of a global organization committed to improving patient lives worldwide.
Equal Opportunity Employer: Pfizer is committed to creating a diverse and inclusive workplace and complies with all applicable equal employment opportunity legislation.
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Sheffield |Oxfordshire :
Witney |Ontario :
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Auckland |New Zealand :
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Japan | Saitama |Tokyo :
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