Associate Manager I - Reg CMC Strategy (LEC Team)

Associate Manager I - Reg CMC Strategy (LEC Team)

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 Reg Atlas 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.

·       Must be extremely organized as LEC projects can run across multiple products/markets.

·       Ensures compliance to Pfizer internal procedures and training SOPs.

·      Ownership of process improvements, metrics and delivery risks

·       Team player and work under matrix environment

·       Works under the supervision of line manager

. Escalation management and cross-functional issue resolution.

·      Accountability for defined team milestones, rather than only assigned individual activities.

·      Technical coaching or knowledge sharing within the work team.

·       Takes responsibility for a portion of the work team’s milestones/ deliverables.

. Any other requests as assigned by line managers.

QUALIFICATIONS / SKILLS

Preferred Education:

Minimum – Postgraduate in Pharmacy

Preferred Experience:

Minimum 7 Years 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.

Advanced level of knowledge on general standards, processes, regulatory guidances and policies of Pfizer/Pharmaceutical manufacturing Industry.

Remain knowledgeable about current regulations and guidance, interprets 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

Experience Level

Mid Level