Pfizer is hiring for the position of Associate II – Reg CMC Strategy in its Regulatory Affairs function. This opportunity is ideal for Pharmacy and Science graduates or postgraduates with 2–4 years of Regulatory Affairs experience who want to work in CMC regulatory strategy, post-approval changes, license renewals, and Annual Reports.

The selected candidate will support the Brands CMC Strategist and collaborate with the CMC Global Regulatory Strategist (GRS-CMC) and multiple cross-functional teams to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets.

Pfizer Associate II – Reg CMC Strategy Job Overview

Pfizer Regulatory Affairs Job Responsibilities

The Associate II – Reg CMC Strategy will manage day-to-day regulatory activities related to assigned Renewals and Annual Reports while working within agreed timelines.

Renewals CMC Responsibilities

Key responsibilities include:

• Support Renewal Strategists in preparing CMC contributions for renewal applications across global markets.
• Author and compile CMC documentation, including:
  • Module 1
  • Module 2.3.S/P
  • Module 3.2.S/P/R/A
• Collaborate with GRS-CMC and RRHS teams.
• Liaise with Pfizer Global Supply and other support functions.
• Apply relevant regulatory guidelines while authoring renewal documentation.
• Execute regulatory strategies while considering registered product content.
• Support regulatory queries and commitment management.
• Review technical and supporting information for renewal submissions.
• Update impacted regulatory dossier components.
• Support risk identification and mitigation activities.
• Escalate potential timeline delays and regulatory risks.
• Coordinate Module 1 and Module 3.2.R ancillary documents.
• Coordinate internal document review and sign-off activities.
• Utilize Pfizer regulatory systems such as PEARL, GDMS, PDM, and SPA.

Annual Report CMC Responsibilities

The selected candidate will also support Annual Report (AR) CMC activities, including:

• Review changes implemented during the reporting period.
• Ensure completeness and accuracy of regulatory information.
• Develop initial Annual Report regulatory strategies.
• Author and compile CMC contributions for regulatory submissions.
• Prepare documentation related to Modules 1 and 3.
• Review post-approval changes submitted and approved.
• Review regulatory commitments and confirm completion.
• Review technical and supporting documentation.
• Manage and review stability-related contributions.
• Apply relevant U.S. regulatory guidelines for Annual Report filing classifications.
• Develop technical justifications for regulatory agency submissions.
• Update impacted dossier components.
• Coordinate Module 3.2.R ancillary documents.
• Identify and escalate timeline delays and regulatory risks.
• Coordinate internal document review and approval activities.
• Work with Pfizer CMC systems, including GDMS, PDM, and SPA.
• Ensure compliance with Pfizer internal procedures, policies, and training SOPs.

Qualifications Required

Educational Qualification

Pfizer has specified the following preferred education:

🎓 Undergraduate or Postgraduate in Pharmacy or Science

Eligible Degrees May Include:

• B.Pharm
• M.Pharm
• B.Sc
• M.Sc
• Other relevant undergraduate or postgraduate degrees in Pharmacy or Science

Candidates should have a relevant academic background suitable for working in the pharmaceutical Regulatory Affairs function.

Experience Required

💼 2–4 years of experience

Candidates should preferably have experience working independently in a Regulatory Affairs function within a reputed pharmaceutical organization.

Experience in the following areas can be valuable:

• Regulatory Affairs
• CMC Regulatory Affairs
• Post-Approval Changes
• Regulatory Submissions
• License Renewals
• Annual Reports
• Pharmaceutical Dossiers
• Global Regulatory Requirements

Required Skills

The ideal candidate should have knowledge of:

• Regulatory Affairs
• CMC Regulatory Strategy
• Global Regulatory Requirements
• Post-Approval Changes
• License Renewals
• Annual Reports
• Regulatory Submissions
• Pharmaceutical Manufacturing
• Regulatory Agency Databases
• Company Regulatory Systems
• Technical Documentation
• Dossier Management
• PEARL
• GDMS
• PDM
• SPA

Preferred Candidate Attributes

Pfizer is looking for professionals with:

• Excellent oral and written communication skills
• Strong analytical abilities
• Good conceptual and reasoning skills
• Problem-solving capabilities
• Strong organizational skills
• Excellent attention to detail
• Ability to manage multiple regulatory activities
• Ability to work effectively with cross-functional teams

Why Join Pfizer?

Working at Pfizer provides an opportunity to gain experience in a global pharmaceutical environment.

Potential Career Benefits

• 🌍 Exposure to global Regulatory Affairs activities
• 📄 Experience in CMC regulatory submissions
• 🤝 Collaboration with international cross-functional teams
• 📈 Career development opportunities in Regulatory Affairs
• 🧪 Exposure to pharmaceutical manufacturing and post-approval changes
• 📊 Experience with regulatory information management systems
• 💡 Opportunity to work on complex global regulatory strategies

Who Should Apply?

This Pfizer Regulatory Affairs job may be suitable for professionals who:

✔ Have a B.Pharm, M.Pharm, B.Sc, M.Sc, or relevant Pharmacy/Science degree

✔ Have 2–4 years of Regulatory Affairs experience

✔ Have experience in pharmaceutical regulatory documentation

✔ Understand post-approval changes and regulatory submissions

✔ Want to develop a career in CMC Regulatory Affairs

✔ Have strong analytical, communication, and organizational skills

How to Apply

Application Link