Regulatory CMC Manager
Responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of company products
Minimum Level of Education Required: BSc in Life sciences or related scientific discipline
Minimum Experience Required: 4 – 5 years of experience in CMC Regulatory Affairs, ideally in biological/Vaccine field.
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
- Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for marketed products.
- Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
- Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
- Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
- Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
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