PHARMAFull-time
Associate I– Reg CMC Strategy (LEC Team)
CHENNAI (IN)ONSITEPOSTED: 9/19/2026
PHARMAFull-time
HIRING ORGANIZATIONPFIZERBiopharmaceutical / Healthcare
ROLE OVERVIEW
Associate I supporting Regulatory CMC Strategy activities for Legal Entity Change variations across global markets, including regulatory assessments, document coordination, CMC authoring, submission planning, and regulatory database activities.
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
- •Perform Market Impact Assessments for entity name changes
- •Use RegAtlas to determine filing actions and impacted regulatory sections
- •Search regulatory databases for CTD components and coordinate document requests
- •Coordinate with markets, sites, ancillary document teams, and responsible disciplines to meet submission timelines
- •Author impacted CMC Module 3 sections under guidance from product strategists and obtain required approvals
- •Use Pfizer CMC systems including GDMS, PDM, SPA, PEARL, RegAtlas, and Rosetta while following internal procedures and SOPs
Reporting Hierarchy: Works under the supervision of a line manager and collaborates with Global Regulatory Strategists, Regional Regulatory Leads, markets, sites, center functions, and cross-functional disciplines
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Minimum postgraduate qualification in Pharmacy
- 0-1 year experience in independently leading Regulatory Sciences activities in a reputed pharmaceutical organization
- Knowledge of NDAs, ANDAs, MAAs, CTDs, and other regulatory components
- Strong oral and written English communication skills
- Good analytical, problem-solving, reasoning, organizational, prioritization, and attention-to-detail skills
PREFERRED QUALIFICATIONS
- •Knowledge of post-approval regulatory requirements for US, EU, and ROW markets
- •Knowledge of oral solid dosage and sterile injectable manufacturing and regulatory data requirements
- •Experience retrieving information from company and regulatory agency databases
- •Knowledge of pharmaceutical regulatory standards, processes, guidance, and policies
REQUIRED VERIFIED SKILLS
Regulatory Affairs
Regulatory CMC
Legal Entity Changes
CMC Strategy
Post-Approval Changes
CTD
Module 3
NDA
ANDA
MAA
Market Impact Assessment
RegAtlas
GDMS
PDM
SPA
PEARL
Rosetta
Regulatory Databases
Submission Grouping
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard Pfizer employee benefits are not specifically detailed in the provided posting.
Salary is not disclosed in the provided posting; no compensation figures are inferred.
ORGANIZATION CONTEXT & CULTURE
Pfizer is a global pharmaceutical company focused on discovering, developing, manufacturing, and delivering medicines and vaccines.
TEAM SIZE: 80,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare
Culture: The role emphasizes regulatory accuracy, cross-functional collaboration, global coordination, change agility, prioritization, compliance, and attention to detail.
EXPECTED CAREER ROADMAP
This entry-level Regulatory CMC role can build toward Regulatory Affairs Specialist, Regulatory CMC Strategist, Senior Regulatory Associate, Global Regulatory Strategist, or regulatory project leadership positions as experience and technical expertise develop.
APPLICATION ADVISORY
Highlight a postgraduate Pharmacy qualification and any Regulatory Affairs exposure; emphasize knowledge of CTD, Module 3, NDA, ANDA, MAA, and post-approval changes; mention familiarity with US/EU/ROW regulatory requirements; showcase analytical, organizational, communication, prioritization, and attention-to-detail skills; include any exposure to regulatory databases or CMC documentation.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.