PHARMAFull-time
Associate I – Reg CMC Strategy (LEC Team)
CHENNAI (IN)ONSITEPOSTED: 9/19/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Support Regulatory CMC Strategy activities for Legal Entity Change variations across US, EU and ROW markets, coordinating global regulatory inputs, authoring impacted Module 3 sections and maintaining submission timelines under manager supervision.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage day-to-day regulatory activities for assigned Legal Entity Change variations within timelines
- •Evaluate change controls for completeness, accuracy and supporting documentation and initiate controls when required
- •Perform Market Impact Assessments for entity name changes
- •Use RegAtlas to determine filing actions and impacted sections and obtain Regional Regulatory Lead confirmation
- •Search regulatory databases and retrieve CTD components or coordinate with market contacts
- •Apply global Legal Entity Change filing guidelines and submission-grouping practices
- •Request required documents from sites, markets and functional teams including ancillary documentation
- •Communicate with markets and follow up with responsible disciplines to meet timelines
- •Author impacted CMC Module 3 sections under product-strategist guidance
- •Obtain GRS CMC approval through Reg-459 and use Pfizer CMC systems as required
- •Maintain compliance with Pfizer procedures and training SOPs
Reporting Hierarchy: Works under the supervision of a line manager within the Brands-LEC Regulatory CMC Strategy team and collaborates with Global Regulatory Strategists, Regional Regulatory Leads, product strategists, market contacts and cross-functional disciplines.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Postgraduate degree in Pharmacy
- 0-1 year experience in Regulatory Sciences in a pharmaceutical organization
- Knowledge of NDAs, ANDAs, MAAs, CTDs and regulatory components
- Knowledge of post-approval regulatory requirements for US, EU and ROW markets
- Strong English communication, analytical, problem-solving and organizational skills
- Attention to detail and accuracy
PREFERRED QUALIFICATIONS
- •Knowledge of Oral Solid Dosage and sterile injectable manufacturing and regulatory data requirements
- •Experience retrieving information from company and regulatory-agency databases
- •Familiarity with current pharmaceutical regulations, guidance and policies
- •Ability to prioritize projects with minimum guidance and adapt to change
REQUIRED VERIFIED SKILLS
Regulatory CMC
Legal Entity Change
LEC variations
Market Impact Assessment
RegAtlas
Module 3
CTD
NDAs
ANDAs
MAAs
post-approval changes
US regulatory requirements
EU regulatory requirements
ROW regulatory requirements
change controls
regulatory databases
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Professional development and training opportunities; Pfizer internal procedures and training support; equal-opportunity workplace. Specific benefits are not disclosed in the posting.
The posting does not disclose a salary range, bonus or equity package. Compensation should therefore be confirmed directly with Pfizer during recruitment.
ORGANIZATION CONTEXT & CULTURE
Pfizer is a global pharmaceutical and healthcare company focused on discovering, developing and delivering medicines and vaccines, with operations across global markets.
TEAM SIZE: Large global pharmaceutical organization; exact employee count not stated in the posting
INDUSTRY: Biopharmaceutical / Healthcare
Culture: The posting emphasizes collaboration, regulatory rigor, accuracy, adaptability, prioritization, professional development and compliance with internal procedures.
EXPECTED CAREER ROADMAP
Potential progression may include Regulatory Affairs Associate, Regulatory CMC Strategist, Regulatory Strategy roles or broader global CMC regulatory positions as expertise in submissions, regulatory strategy and cross-market coordination develops.
APPLICATION ADVISORY
Highlight postgraduate Pharmacy qualification and any Regulatory Affairs exposure; emphasize knowledge of CTD, NDA, ANDA, MAA and post-approval changes; demonstrate understanding of CMC Module 3 and pharmaceutical manufacturing data; mention familiarity with US, EU and ROW regulatory requirements; highlight analytical ability, attention to detail, communication and prioritization; mention exposure to regulatory databases or CMC systems if applicable.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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