Manager, Regulatory Affairs – CMC
We have multiple openings to join G&L’s Regulatory team in North America. You would be joining a large team of industry-leading RA consultants, assigned to client engagements with a CMC and vaccine focus.
Project responsibilities will include:
- Develop effective relationships with local & global client stakeholders
- 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 & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
- Manage regulatory issues, maintain submission information in relevant systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
- Serves as a technical and scientific resource within own work group/discipline and provides guidance for 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 companies regulatory success
- May participate in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to GCMC functions.
- Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
- Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
- Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
Previous experience should include:
- 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 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
- Managing colleagues within a GCMC function, only if the position requires supervision of personnel.
- 2+ years’ management & supervisory experience with technical project and/or staff.
- Conformance/Quality experience in pharmaceutical or other regulated industry is strongly desired.
- Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
- Strong understanding of CMC change management processes and CMC CTD content/structure.
- Advanced skills in written & oral communications are mandatory.
- Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.
- 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.
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