CMC Regulatory Project Manager
- Bachelor's degree in life sciences or related scientific discipline.
- Sound knowledge of worldwide CMC regulatory requirements for biopharmaceutical products.
- Detailed knowledge of biopharmaceutical drug development and manufacturing/supply processes.
- Minimum of 5 years' experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions
- Experience in CMC regulatory affairs is preferable.
- Experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins) is preferable.
- Ability to manage and lead multiple projects/teams simultaneously.
- Global CMC Regulatory experience with biopharmaceuticals (e.g., monoclonal antibodies and therapeutic proteins).
- Continued professional growth in global regulatory affairs, including communication of evolving trends and policies.
- Broad knowledge base of regulatory functions to understand wider implications of emerging issues across projects.
- Experience in influencing and negotiating with technical personnel in a variety of settings.
- Strong technical writing skills and attention to detail.
- Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
- Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
- Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA, supplements, variations) is preferable
- Expert knowledge and hands-on experience in at least one area related to CMC Biopharm product development (e.g. analytical or process development, manufacturing, quality control).
Represents Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams and other functions.
Understands and advises on regulations, guidelines, procedures, and policies relating to the development, successful global registrations, and manufacture of biopharmaceutical products, to expedite submission, review, and approval of global CMC applications.
Ensures all appropriate CMC regulatory aspects for clinical trials, product release, and stability are in place.
Supports license maintenance, change control requests, and post-approval submissions, ensuring delivery to agreed timelines.
Manages multiple projects and teams simultaneously.
Contributes to and leads the improvement of GSK's CMC regulatory processes, policies, and systems.
Communicates across the company to influence CMC project and policy issues that are aligned with business needs.
- Provide guidance to functional area authors/reviewers with regards to clinical and marketing submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.
- Directly manage completion of multiple dossier components to meet project timelines.
- Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed.
- Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements.
- Work closely with project team members and CMC regulatory team to produce high quality submissions.
- Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes.
- Effectively adjust plans to deal with changes and obstacles.
- Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions.
- Organize and archive CMC dossier components and supporting documents in appropriate document management systems.
- Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities.
You may apply for this position online by selecting the Apply now button.
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