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 : Manager/Team Lead Regulatory CMC, Upjohn
Job Description
• 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.
• 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.
Candidate Profile
• 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.
Additional Information
Qualification : B.Pharm
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory CMC
End Date : 25th May, 2020
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