Pfizer has announced two Regulatory CMC Strategy job openings in Chennai, India, within its Brands–LEC (Legal Entity Change) team. The vacancies are for Associate I – Reg CMC Strategy (LEC Team) and Associate Manager I – Reg CMC Strategy (LEC Team).

These roles involve supporting regulatory activities associated with Legal Entity Changes across the US, EU and Rest of World (ROW) markets. Responsibilities include regulatory assessment, submission planning, documentation coordination, CMC regulatory strategy and authoring impacted Module 3 sections.

Both positions require a minimum postgraduate qualification in Pharmacy, while the required experience differs substantially between the two roles.

Pfizer Regulatory CMC Strategy Jobs – Overview

1. Associate I – Reg CMC Strategy

The Associate I – Reg CMC Strategy will support Regulatory CMC activities for the Brands–LEC team. The position works with Global Regulatory Strategists and cross-functional teams to coordinate regulatory requirements associated with legal entity changes.

Key Responsibilities

The Associate I will be responsible for:

• Managing day-to-day regulatory activities related to Legal Entity Change variations.
• Reviewing change controls and supporting documentation for completeness.
• Performing Market Impact Assessments.
• Using RegAtlas to identify filing actions and impacted regulatory sections.
• Searching regulatory databases for Common Technical Document (CTD) components.
• Supporting LEC filing requirements across global markets.
• Applying global and regional CMC regulatory policies.
• Coordinating with sites, markets and internal functions to obtain required documents.
• Communicating with markets regarding clarification and prioritization.
• Following up with responsible disciplines to meet submission timelines.
• Authoring impacted CMC Module 3 sections under appropriate guidance.
• Obtaining required approvals from GRS CMC teams.
• Working with Pfizer systems and databases, including GDMS, PDM, SPA, PEARL, RegAtlas and Rosetta.
• Following Pfizer procedures, SOPs and required training.

Eligibility Criteria

Educational Qualification

• Minimum postgraduate qualification in Pharmacy.

Experience

• 0–1 year of experience in independently leading activities within Regulatory Sciences, as specified in the job posting.
• Knowledge of regulatory submissions and components including NDAs, ANDAs, MAAs and CTDs.

Skills Required

Candidates should have knowledge of:

• Post-approval regulatory changes.
• US, EU and ROW regulatory requirements.
• CMC regulatory submissions.
• Oral solid dosage manufacturing and regulatory requirements.
• Sterile injectable manufacturing and regulatory requirements.
• Regulatory databases.
• Pharmaceutical regulatory standards, processes and guidance.

2. Associate Manager I – Reg CMC Strategy

The Associate Manager I – Reg CMC Strategy role carries similar core Regulatory CMC responsibilities but requires significantly greater experience and accountability.

The position involves managing regulatory activities, coordinating stakeholders, supporting submission strategies and taking ownership of defined deliverables within the Brands–LEC team.

Key Responsibilities

The Associate Manager I will:

• Manage Legal Entity Change regulatory activities.
• Evaluate change controls and supporting documentation.
• Perform Market Impact Assessments.
• Determine filing actions and impacted CTD sections using RegAtlas.
• Retrieve CTD components from regulatory databases and market contacts.
• Apply global LEC filing guidelines.
• Manage submission grouping activities.
• Interpret global and regional CMC regulatory policies.
• Coordinate documentation with sites, markets and internal functions.
• Author impacted Module 3 CMC sections.
• Coordinate approvals with GRS CMC teams.
• Work with Pfizer systems including GDMS, PDM, SPA, PEARL, RegAtlas and Rosetta.
• Support process improvements and performance metrics.
• Identify and manage delivery risks.
• Handle escalations and cross-functional issues.
• Take accountability for defined team milestones and deliverables.
• Provide technical coaching and knowledge sharing.

Eligibility Criteria

Educational Qualification

• Minimum postgraduate qualification in Pharmacy.

Experience

• Minimum 7 years of relevant Regulatory Sciences experience in a reputed pharmaceutical organization.
• Experience independently leading Regulatory Sciences activities.
• Knowledge of NDAs, ANDAs, MAAs, CTDs and related regulatory components.

Skills Required

The role requires advanced knowledge of:

• Post-approval regulatory requirements in the US, EU and ROW.
• CMC regulatory requirements.
• Oral solid dosage forms.
• Sterile injectable manufacturing and regulatory requirements.
• Regulatory databases.
• Pharmaceutical regulatory standards and processes.
• Regulatory guidance and policies.

Who Can Apply for Pfizer Regulatory CMC Jobs?

The two positions target different experience levels.

The Associate I opportunity is relevant to candidates with a postgraduate Pharmacy qualification and early-career Regulatory Sciences experience, subject to the specific requirements stated in the posting.

The Associate Manager I position is intended for experienced Regulatory Sciences professionals with at least 7 years of relevant experience.

Candidates with backgrounds in areas such as Regulatory Affairs, CMC Regulatory Strategy, post-approval submissions and pharmaceutical regulatory operations may find these positions relevant if they meet the stated educational and experience requirements.

Important Skills for These Roles

Pfizer’s Regulatory CMC Strategy positions require a combination of regulatory knowledge and cross-functional working skills, including:

• Regulatory Affairs knowledge
• CMC regulatory strategy
• CTD documentation
• Module 3 authoring
• Post-approval regulatory submissions
• US/EU/ROW regulatory requirements
• Analytical and problem-solving skills
• Regulatory documentation accuracy
• Written and verbal communication
• Organization and prioritization
• Cross-functional collaboration
• Regulatory timeline management
• Ability to work in a matrix organization
• Change agility

Job Location and Work Type

Company: Pfizer
Location: Pfizer Centre, Chennai, India
Job Type: Full-time
Function: Regulatory CMC Strategy
Team: Brands – LEC (Legal Entity Change)

How to Apply

Application Link For Associate I – Reg CMC Strategy (LEC Team)

Application Link For Associate Manager I – Reg CMC Strategy (LEC Team)