Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Assistant Manager, Regulatory Affairs CMC, Upjohn
The Assistant Manager, Regulatory Affairs CMC, Upjohn, possesses CMC regulatory knowledge and quality expertise to independently prepare regulatory assessments & contribute to global regulatory 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, regulatory submission quality, 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.
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.
• 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.• 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 conceptsof a regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
Qualification : M.Pharm, B.Pharm, MSc
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th March, 2021
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