Manager, CMC Vaccines

REF: 1045

A flexible opportunity for a Regulatory Affairs professional with experience in vaccines and CMC.

• Develop effective relationships with local & global internal partners
• Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
• Contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
• Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
• Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & develop plans to develop global regulatory strategies for programs by regulatory, scientific & technical criteria.
• Manage regulatory issues, maintain submission information in relevant global CMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Serves as a technical and scientific resource within own workgroup/discipline and guides completion of difficult and complex projects.
• Providing guidance & direction for direct reports, managing global resources & resource capacity along with prioritizing workload appropriately.
• Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
• Develop relationships with regulatory authorities to improve the company’s regulatory success
• Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to developing global regulatory strategies for programs by regulatory, scientific & technical criteria.
• Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

QUALIFICATIONS / SKILLS

• 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 of pharmaceutical regulatory experience.
• Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
• Experience operating within GMP, GLP, or GCP related SOPs.
• Product release system exposure helpful
• Strong understanding of CMC change management processes and CMC CTD content/structure.
• Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools
• Prior experience managing projects is preferred.
• Lean and/or SixSigma experience helpful.