If you’re looking for Regulatory Affairs jobs in Chennai, Pfizer has announced an excellent opportunity for professionals interested in Chemistry, Manufacturing and Controls (CMC) Regulatory Strategy. The Associate II – Reg CMC Strategy position offers the chance to work on global pharmaceutical products, regulatory submissions, compliance activities, and post-approval lifecycle management while collaborating with cross-functional international teams.

This Pfizer Regulatory Affairs job is ideal for candidates with experience in pharmaceutical regulatory submissions, CMC documentation, lifecycle management, and global regulatory compliance. The role follows a hybrid work model based in Chennai, India.

Job Overview

About the Role

The Associate II – Reg CMC Strategy is responsible for developing and executing global CMC regulatory strategies for commercial pharmaceutical products. The role supports post-approval regulatory submissions, regulatory compliance, and strategic planning for product lifecycle management.

The successful candidate will collaborate with global cross-functional teams, prepare high-quality CMC documentation, evaluate regulatory risks, and ensure timely submissions to worldwide health authorities.

This is an excellent opportunity for professionals seeking Pfizer jobs in India, CMC Regulatory Affairs careers, and Regulatory Strategy positions.

Key Responsibilities

As an Associate II – Reg CMC Strategy, you will:

• Develop global CMC regulatory strategies for commercial pharmaceutical products.
• Prepare and manage CMC documentation for regulatory submissions.
• Support global post-approval regulatory activities.
• Coordinate regulatory lifecycle management activities.
• Assess regulatory risks and develop mitigation strategies.
• Collaborate with manufacturing, quality, supply chain, and global regulatory teams.
• Interpret international regulatory guidelines and evaluate their impact on business strategy.
• Manage assigned products and regulatory deliverables independently.
• Support compliance initiatives and regulatory commitments.
• Participate in cross-functional meetings representing CMC Regulatory Affairs.
• Resolve routine regulatory issues while escalating complex risks appropriately.
• Maintain compliance with Pfizer quality systems and internal procedures.
• Utilize Pfizer regulatory systems including:
  • GDMS
  • PDM
  • SPA
  • Rosetta
  • PEARL

Required Qualifications

Candidates are expected to have:

• Bachelor’s or Master’s degree in:
  • Pharmacy
  • Pharmaceutical Sciences
  • Life Sciences
  • Chemistry
  • Biotechnology
  • Related discipline
• Experience in Regulatory Affairs or CMC Regulatory Strategy preferred.
• Knowledge of:
  • Global CMC regulations
  • Regulatory submissions
  • Pharmaceutical manufacturing
  • Product lifecycle management
  • Post-approval change management
• Strong communication and project management skills.
• Ability to work with global cross-functional teams.

Preferred Skills

• CMC dossier preparation
• Regulatory compliance
• Risk assessment
• Technical writing
• Global health authority submissions
• Documentation management
• Pharmaceutical product lifecycle management
• Problem-solving abilities
• Stakeholder management

Why Join Pfizer?

Working at Pfizer offers professionals an opportunity to contribute to medicines that improve patient lives worldwide.

Benefits include

• Hybrid work model
• Global career opportunities
• International regulatory exposure
• Learning and development programs
• Cross-functional collaboration
• Competitive salary and benefits
• Inclusive workplace culture
• Career progression in Regulatory Affairs

Salary

Based on similar Regulatory Affairs positions in Chennai, the estimated salary range is:

₹8,50,000 – ₹14,00,000 per annum (CTC)

Actual compensation depends on qualifications, experience, internal equity, and Pfizer’s hiring policies.

Job Location

Chennai, Tamil Nadu, India (Hybrid)

How to Apply

Application Link