Functions as a CMC
- Regulatory Strategist working with Global Regulatory Strategists (GRS-CMC) to updated and maintain CMC deficiency database. To do analysis/trending of deficiencies received. Other actives may include working with GRS-CMC and Cross Functional Teams to prepare and submit CMC strategies/ submissions for the assigned activities/products in support of clinical program. The regulatory activities may include authoring /supporting CMC strategies & CMC contents for IND/IMPD/ROW IMPDs & NDA/MAA/ ROW dossier independently and in support of Global team. Provide operational global CMC regulatory support and documentation for assigned projects/products covering initial registrations and approval activities of various complexities / risks. Perform regulatory fact fi nding for the preparation of CMC information for submission to global regulatory agencies. Maintain CMC systems and perform data management. Also, responsible for complete review of the assigned CMC submissions packages and associ-ated system-based tasks. Provides mentoring/training support for junior staffs.
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Job Responsibilities:
Functions as a CMC -Regulatory strategists responsible for the assigned CMC activities of various complexity/risk related to clinical development programs with in Global - Brands. The responsibilities include, but not limited to the following.
-To updated and maintain CMC deficiency database. To do analysis/trending of deficiencies received.
-To work with PCO and RRHS so that RRM remains updated with the current requirements.
-Provide review support of the assigned CMC submissions authored by other team members.
-Assist in gathering and interpreting global clinical submission CMC requirements using systems and/or in collaboration with country regulatory leads for the development of regulatory strategy.
-May develop/support authoring regulatory strategies for global/regional markets for the assigned programs/products to support registrations.
-Assist in authoring IND / IMPD/ NDA/MMA and ROW CMC dossiers and submissions activities Independently author ROW IMPD CMC dossiers in close collaboration with the CMC Lead and coordinate quality review according to internal procedures as well as sign-off procedures (Reg-456/459 reviews).
-Assist in collection of supporting documentation from Pharm Sci, PGS, etc. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
-Support CMC systems maintenance and publishing activities (e.g. SPA, PDM, etc.,).
-Liaise with RCM as needed.
-Support clinical CMC activities for the existing portfolio, e.g., CMC activities to support BE, pediatric development, etc.,
-Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects within a work team.
-Ensure compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs.
-Assess scientific opinions and assist in developing regulatory strategies and documentation.
-Recommend solutions for issues of various complexities and escalates issues with significant business impact where necessary.
-Assist in the development of resolution proposals for moderate regulatory CMC/information management issues in support of project/program stakeholders.
-Updates ancillary document requests in appropriate system, as needed.
-Provides mentoring/training support on technical aspects of the team (end to end, from strategy building through authoring submissions), Pfizer System and processes to junior staffs.
Work Location Assignment: On Premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
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