Associate I - Reg CMC Strategy (LEC Team)

Pfizer; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Pfizer seeks a Strategist for Brands-LEC to collaborate with Global Regulatory Strategist and cross-functional teams. You will prepare and submit entity name change variations across US, EU, and ROW within defined timelines.

Responsibilities include regulatory activities, change control evaluation, and compiling CMC sections under guidance. You will use RegAtlas and other Pfizer systems to ensure compliant submissions.

Qualifications

• Excellent oral and written English communication skills.
• Knowledge of NDAs, ANDAs, MAAs, CTDs and other regulatory components.
• Strong analytical, problem solving and organizational skills.

Responsibilities

• Manages day-to-day regulatory activities for LEC variations within timelines.
• Evaluate change controls for completeness and accuracy with supporting documents.
• Perform Market Impact Assessment (MIA) for entity name change.
• Run RegAtlas to determine filing actions and obtain confirmations from Regional Regulatory Lead.
• Search regulatory databases for CMC components and request documents as needed.
• Familiar with global guidelines for filing Legal Entity Changes (LEC).
• Interpret and apply global/regional CMC regulatory policies.
• Request documents from sites/markets and ancillary teams as needed.
• Communicate with markets for clarification and prioritization.
• Author modules in CMC sections (Module 3) under guidance and timelines.
• Obtain approval in Reg-459 form from GRS CMCs after authoring sections.
• Utilize Pfizer CMC systems (GDMS, PDM, SPA, PEARL, RegAtlas, Rosetta).
• Work under line manager supervision and comply with SOPs.

Skills

English communication

Regulatory knowledge

Attention to detail

Project prioritization

Education

Postgraduate in Pharmacy

Job description

JOB SUMMARY

Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and Cross Functional Teams to prepare and submit the variations for entity name change across global markets including US, EU & ROW as per defined timelines.

JOB RESPONSIBILITIES

• Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines.
• Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed.
• Performs Market Impact Assessment (MIA) for the specific entity name change.
• Runs the RegAtlas to determine the filing action and impacted sections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
• Search Regulatory databases for Common Technical Document components or request them from appropriate market contacts, when not available.
• Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database.
• Should be familiar with submission grouping practices.
• Interpret and apply global/regional CMC regulatory policies.
• Request documents from the sites/markets/center functions as needed.
• Request Ancillary documents from Ancillary documents team.
• Communicate with markets if clarification/prioritization is needed.
• Follow up with all responsible disciplines to be able to meet timelines.
• Authoring of the impacted CMC sections i.e. Module 3 under the guidance from the product strategists as appropriate and within agreed timelines.
• Responsible for obtaining approval in Reg-459 form from GRS CMCs on the completion of authoring the sections.
• Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, PEARL, RegAtlas, Rosetta etc., as appropriate.
• Works under the supervision of line manager
• Ensures compliance to Pfizer internal procedures and training SOPs.
• . Any other requests as assigned by line managers

QUALIFICATIONS / SKILLS

Preferred Education: Minimum - Postgraduate in Pharmacy

Preferred Experience: 0-1 year in leading independently in the Regulatory Sciences function in a reputed Pharmaceutical Organization . Knowledge of NDAs, ANDAs, MAAs, CTDs and other regulatory components.

Preferred Attributes: Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, reasoning and organizational skills. Should be change agile, prioritization of projects with minimum guidance. Attention to detail and accuracy required.

Technical Skills:

Regulatory requirements of post approval changes for US, EU and ROW markets. Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for post approval submissions. Knowledge in retrieving information from company's and regulatory agency databases. Basic level of knowledge on general standards, processes, regulatory guidances and policies of Pfizer/Pharmaceutical manufacturing Industry. Remain knowledgeable about current regulations and guidance, interpret and notifies appropriate personnel.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs