Regulatory Project Manager (Chemist, Manufacturing and Controls) - Multiple Opportunities
We are seeking a number of highly motivated Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Group. Within Global Regulatory Affairs, the CMC organisation provides regulatory leadership to CMC teams encompassing Pharma Supply Chain (PSC), Technical and Quality representatives and Local Operating Companies to enable an uninterrupted supply of our medicines to patients. Our work spans all formulation types and markets for marketed small molecules.
We currently have a number of excellent opportunities to work on exciting projects as well as influence and shape new ways of working. As Regulatory Project Manager (CMC), you will be responsible for the provision of CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets. This is an interesting and fast paced role which will provide opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries.
Key responsibilities include maintenance of the global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in the cross-functional Regulatory Product Matrix teams. In delivering your objectives you will partner with the manufacturing organisation (both Technical and Quality) to provide strategic regulatory advice for change controls, develop regulatory strategies and plans (through to implementation), and lead authoring of the variation dossiers and responses to Regulatory Agency questions.
LOCATION - This role can be based at GSK House (Brentford, West London) or at the Research Triangle Park (RTP) (North Carolina, USA).
This role involves the development of regulatory strategy and implementation of changes to global processes across multiple locations and stakeholders from the Manufacturing business-units. The roles would suit a driven and motivated individual who has strong experience of working in a complex Regulatory environment. You will have excellent people skills and be able to work across boundaries. You will need to be open-minded, with excellent communication skills and have proven experience dealing with diverse stakeholder groups. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise.
- Degree Qualified in suitable discipline (eg; Pharmacy, Chemistry or related scientific discipline)
- Relevant experiences and/or qualifications in regulatory oversite (in multiple counties).
When applying for this role, please use your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you provide in your CV will be used to assess your application.
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