2 days old

Manager

Pfizer
Chennai
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**JOB SUMMARY**



Summarize the primary purpose & key accountabilities of the job.



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. Also responsible for complete review of the assigned CMC submissions packages and associated system based tasks. Provides provides mentoring/training support for junior staffs.



**JOB RESPONSIBILITIES**



Indicate the primary responsibilities critical to the job.



+ Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines of self and supporting the LEC team members.

+ Responsible for complete review of the assigned CMC submissions authored by other LEC team members.

+ 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 Regulatory Requirement Manager 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 CMC GRL as appropriate and within agreed timelines.

+ Responsible for obtaining the approval in Reg-459 form from GRL on the completion of authoring the sections.



+ Provides mentoring/training support on technical aspects of LEC (end to end, from strategy buiding through authoring submissions), Pfizer System and processes to junior staffs.



+ Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, 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(Power 2 Learn).



**QUALIFICATIONS / SKILLS**



Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.



+ **Preferred Education:**



Minimum - Postgraduate in Pharmacy / Science



+ **Preferred Experience:**



Minimum 8 Years in leading independently in the Regulatory Affairs 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, inter personal, analytical, problem solving, reasoning and organizational skills. Should be change agile, prioritization of projects with minimum guidance, have ability to work in highly matrixed environment. Attention to detail, accuracy and team management skills 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, 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.



Regulatory Affairs



\#LI-PFE
Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Manager

Pfizer
Chennai

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