Job Description:
Accountability:
- 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 & Responsibility:
- 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 the 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 the quality review of regulatory CMC submissions.
- Serving as a technical and scientific resource and providing guidance for the 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 to 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 a focused area of expertise.
Qualification: B.Pharma/B.Sc – Bio/Chem/tech
Experience: 10 Years QA/QC/Production/R&D with 3 Years in Regulatory
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