30 days old

Manager/Team Lead Regulatory CMC, Upjohn

Pfizer
Chennai
The Manager/Team Leader, Regulatory CMC Strategy, Upjohn is accountable for:



+ Managing a team of CMC professionals

+ Ensuring regulatory conformance & consistency globally and in compliance with external regulatory requirements & internal quality procedures.

+ Demonstrating regulatory knowledge & experience, balanced judgment, crisp decision-making, exemplary collaboration & business acumen , i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy & quality standards

+ Development and provision of robust regulatory strategies, leveraging both technical & regulatory knowledge, to mitigate risks.

+ Preparation & Delivery of high quality CMC regulatory submissions & submission management plans for global regulatory agencies.

+ Execution of regulatory policies and implementation of policies and operational processes for delivering the product portfolio.



**ROLE RESPONSIBILITIES**

The Manager, Regulatory CMC Strategy, Upjohn is responsible for:



+ Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

+ Managing regulatory issues, maintaining submission information in relevant CMC systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

+ Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.

+ Authoring and/or coordinating CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinating & contributing to responses to Agency queries and performing quality review of regulatory CMC submissions.

+ Serving as a technical and scientific resource and providing guidance for completion of difficult and complex projects.

+ Prioritizing & independently completing assigned workload appropriately.

+ Developing effective relationships with local & global internal partners, i.e., R&D, Global Supply, Quality Operations, Regional and Country Regulatory Leads, Pfizer Regulatory Operations

+ Developing relationships with regulatory authorities to improve Upjohn's regulatory success.

+ Executing training related activities (e.g. compliance-related, HR policies) & individual development plans, participating in cross-disciplinary forums & learning opportunities, engaging in Straight Talk & Listen exchanges, demonstrating & modeling adherence to all Upjohn behaviors & values, embracing & complying with Principles of Integrity.

+ Managing and contributing to CMC-related projects, initiatives & actions.

+ Participating, as required, in pharmaceutical industry conferences or serving externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

+ Mentoring colleagues within focused area of expertise.



**Education and Experience:**



+ Bachelor's degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 6+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.

+ Minimum of 2+ years' experience as a people manager

+ Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.

+ Advanced skills in written & oral communications are mandatory. Excellent communication skills in English are required.

+ Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

+ Prior experience managing projects is preferred.



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Regulatory Affairs

Categories

Posted: 2020-04-28 Expires: 2020-05-28

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Manager/Team Lead Regulatory CMC, Upjohn

Pfizer
Chennai

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