Associate I– Reg CMC Strategy (LEC Team)

Pfizer; Kolkata District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Pfizer seeks a Strategist for Brands-LEC to coordinate global regulatory submissions for entity name changes across US, EU and ROW. You will work with Global Regulatory Strategist and cross-functional teams to prepare variations within defined timelines.

Responsibilities include managing day-to-day regulatory activities, evaluating change controls, conducting Market Impact Assessments, and authoring CMC sections under guidance, while using RegAtlas and other Pfizer systems to meet filing

Qualifications

• Minimum – Postgraduate in Pharmacy.
• 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.
• 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.
• Regulatory requirements of post approval changes for US, EU and ROW markets.

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.

Skills

English communication

Analytical skills

Organizational skills

Problem solving

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