Job Description

Job Summary (not all inclusive):
Functions as a CMC \xe2\x80\x93 Regulatory Strategist working with Global Regulatory Strategists (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 finding 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 associated system-based tasks. Provides mentoring/training support for junior staffs.

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 \xe2\x80\x93 Brands. The responsibilities include, but not limited to the following:

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.

Preferred Education:

Minimum - Postgraduate in Pharmacy or Science

Preferred Experience:

Minimum 9 + years of CMC experience within a regulatory function with knowledge of INDs/IMPDs, NDAs, ANDAs, MAAs, CTDs and other regulatory components.

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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