27 days old

Assistant Manager Regulatory Affairs

Pfizer
Chennai
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The Assistant Manager, Regulatory Affairs CMC, 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.

+ Prioritizing & independently completing assigned workload appropriately 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 and help peer review the variations as required.

+ 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.

+ Developing effective relationships with local & global internal partners, i.e., R&D, PGS, Country Regulatory Leads, other CMC lines.



**Education and Experience:**



+ Bachelor's / Master's degree in pharmaceutical sciences &/or technical discipline with 6-10 years of relevant experience in the pharmaceutical industry and at least 5+ years pharmaceutical regulatory experience.

+ Minimum of 5+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.

+ Advanced skills in written & oral communications are mandatory.

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



**Technical and/or other job-related skills:**



+ Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP's required to assess technical, scientific & regulatory merits of CMC information, commitments and data.

+ Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.

+ An understanding of regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.

+ Updates, interprets, and applies global & regional CMC guidelines. Ability to contribute to global regulatory strategies by proactively discussing with partners.

+ Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

+ Experience engaging in the external regulatory & pharmaceutical environment is preferred.

+ Emerging awareness of new scientific or manufacturing technology.

+ Possesses sound understanding of business expectations across divisions

+ May serve as Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

+ Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.



\#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
Posted: 2020-04-27 Expires: 2020-05-28
Sponsored by:
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Assistant Manager Regulatory Affairs

Pfizer
Chennai

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