Pfizer is hiring an Associate Manager I – Reg CMC Strategy for its Regulatory Affairs function. This opportunity is suitable for experienced CMC Regulatory Affairs professionals with strong knowledge of post-approval changes, global regulatory submissions, CMC documentation, and EU/US regulatory practices.

The selected candidate will support the development and execution of global CMC regulatory strategies for prioritized post-approval changes initiated by Pfizer Global Supply (PGS). The role involves collaboration with the CMC Global Regulatory Strategist (GRS-CMC) and multiple cross-functional teams to ensure timely regulatory submissions and successful management of Health Authority queries.

Pfizer Associate Manager I – Reg CMC Strategy Job Overview

Pfizer Regulatory Affairs Job Description

The Associate Manager I – Reg CMC Strategy will contribute to the execution of CMC regulatory strategies for global post-approval changes.

The professional will work closely with Pfizer Global Supply, CMC GRS, and cross-functional stakeholders to manage assigned regulatory activities, CMC documentation, regulatory submissions, and Health Authority queries.

This Pfizer Regulatory Affairs job provides an opportunity to work on global pharmaceutical products and develop expertise in CMC strategy and international regulatory requirements.

Key Job Responsibilities

CMC Regulatory Strategy

The selected candidate will:

• Function as a CMC author and strategist for assigned regulatory changes.
• Develop and execute regulatory strategies for minor and moderate post-approval changes.
• Support CMC projects and products across global markets.
• Conduct end-to-end PCF assessments.
• Review proposed changes for completeness and accuracy.
• Develop initial global regulatory strategies while considering registered content.
• Obtain appropriate endorsement from the CMC Global Regulatory Strategist (CMC GRS).
• Support complex CMC changes and projects as part of career development and mentoring.

Regulatory Submission Responsibilities

Key responsibilities include:

• Author and compile Regulatory Strategy Documents (RSD).
• Prepare global CMC submission packages.
• Author and compile regulatory documentation, including:
  • Module 1
  • Module 2.3
  • Module 3.2.S/P/R
• Update Module 3 regulatory dossiers.
• Coordinate Module 3.2.R ancillary documents.
• Review technical and supporting information for regulatory submissions.
• Develop technical justifications for changes submitted to regulatory agencies.
• Apply relevant global regulatory guidelines.

Post-Approval Change Management

The Associate Manager will support:

• Global post-approval changes.
• Minor and moderate CMC changes.
• Major and Emerging Market-focused regulatory activities.
• Review and assessment of proposed manufacturing and CMC changes.
• Management of regulatory documentation and information.
• Updating impacted regulatory dossiers.
• Risk identification and mitigation.

Health Authority Query Management

The role also involves:

• Authoring and compiling responses to Health Authority (HA) queries.
• Managing responses within agency-defined timelines.
• Supporting regulatory commitments and query management.
• Collaborating with the CMC GRS during regulatory interactions.

Cross-Functional Collaboration

The selected candidate will collaborate with:

• CMC Global Regulatory Strategists
• Pfizer Global Supply
• RRHS
• PCO
• RCM
• Site CNM
• Other internal stakeholders

The candidate may also represent the GEPRA CMC perspective while working with key stakeholders to resolve regulatory challenges.

Systems and Documentation

The role requires working with regulatory and document management systems, including:

• GDMS
• PDM
• SPA
• TrackWise
• Navigation
• Submission Management Tools
• Document Management Systems
• Publishing Tools
• Regulatory Databases

Qualifications Required

Educational Qualification

🎓 Minimum Qualification:

Postgraduate degree in Pharmacy or Science

Examples of Eligible Degrees

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

⚠️ Important: The official job description specifically mentions a Postgraduate degree in Pharmacy or Science as the minimum qualification.

Experience Required

💼 Minimum Experience: 3–7 Years

Candidates should have:

• 3–7 years of CMC experience within a Regulatory Affairs function
• Experience in pharmaceutical regulatory activities
• Knowledge of global CMC regulatory requirements

Experience with EU, US, and international regulatory practices and policies is required or highly relevant for this role.

Required Skills

Candidates applying for this Pfizer CMC Regulatory Affairs job should have knowledge or experience in:

• Regulatory Affairs
• CMC Regulatory Strategy
• Post-Approval Changes
• Global Regulatory Submissions
• CMC Documentation
• Regulatory Strategy Documents
• Health Authority Queries
• Regulatory Commitments
• EU Regulatory Requirements
• US Regulatory Requirements
• International Regulatory Practices
• Module 1
• Module 2.3
• Module 3
• Regulatory Dossier Management
• Pharmaceutical Manufacturing
• GDMS
• PDM
• SPA
• TrackWise
• Submission Management Systems
• Document Management Systems

Preferred Candidate Attributes

Pfizer is looking for candidates with:

• Excellent verbal and written communication skills
• Strong interpersonal skills
• Analytical and problem-solving abilities
• Strong organizational skills
• Attention to detail and accuracy
• Ability to manage multiple projects
• Good prioritization skills
• Ability to work in a matrix environment
• Adaptability and agility
• Teamwork and collaboration skills
• Customer-focused mindset
• Ability to meet defined timelines
• Willingness to work flexible hours

Why Join Pfizer?

A career in Pfizer Regulatory Affairs can provide exposure to global pharmaceutical regulatory operations and CMC strategy.

Potential Career Benefits

• 🌍 Work on global regulatory strategies
• 📄 Gain experience in CMC regulatory submissions
• 🧪 Work on pharmaceutical post-approval changes
• 🤝 Collaborate with global cross-functional teams
• 📊 Exposure to international regulatory requirements
• 📈 Career development in CMC Regulatory Affairs
• 💡 Work with regulatory systems and submission technologies
• 🌐 Exposure to EU, US, and international markets

Who Should Apply?

This opportunity may be suitable for professionals who:

✅ Hold a Postgraduate degree in Pharmacy or Science

✅ Have 3–7 years of CMC Regulatory Affairs experience

✅ Have experience with post-approval changes

✅ Understand global pharmaceutical regulatory requirements

✅ Have knowledge of EU, US, and international regulations

✅ Have experience with regulatory submissions and dossier management

✅ Are interested in developing their career in CMC Regulatory Strategy

How to Apply

Application Link