Assistant Manager, Regulatory Affairs

Job Description

The Assistant Manager, Regulatory Affairs CMC, Upjohn, possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to globalregulatory strategies for projects across all aspects of drug development or manufacturing lifecycle and works to support the Upjohn product portfolio.The Assistant Manager, Regulatory Affairs CMC, Upjohn is accountable for: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, regulatorysubmission quality, review of policy & quality standardsDevelopment 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.Role ResponsibilitiesThe 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 toresponses 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 pharmaceuticalregulatory 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 businessneeds.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 divisionsMay 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 domainsDemonstrates sound understanding and advanced knowledge of the principles, practices and conceptsof a regulatory CMC/ policy/ publishing disciplines and a working knowledge of theprinciples, practices, concepts and operations in other relevant disciplines.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,

Keyskills :
salesmisaccountstatbankingequal employment opportunityregulatory strategy developmentcontinuous improvement facilitationmusic makingannual reports