Associate II - Reg CMC Strategy, Brands CMC
Job posting number: #7199487 (Ref:pf-4901440)
Posted: December 7, 2023
- Support Product Leads develop CMC regulatory strategies, submissions and compliance activities for pharmatherapeutic development programs and commercial products supporting PBG products registered and marketed within the Asia Pacific (APAC) or Africa and Middle East (AfME) or European Union (EU) region, with supervision.
- Provide operational global CMC regulatory support and documentation for assigned projects/products covering initial registrations and approval/post approval activities of Low and medium complexity/risk. Assembles CMC information for submission to APAC or AfME or EU region regulatory agencies and supports CMC strategies with supervision. Maintains and tracks submission and approval statuses. Perform regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies. Maintain CMC systems and perform data entry.
- Assist cross-functional project teams by scheduling meetings, taking notes and tracking action items independently.
- Opportunity to increase level of complexity and independence with potential career path of CMC Product Lead.
- Fair understanding of regulatory processes and requirements for defined market(s) and able to interpret and apply to projects.
- Works under direct supervision under Team Lead/Designee and manages projects and executes the agreed upon strategies and plans. Supports team in the development of regulatory strategies to support registrations.
- Responsible for authoring CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control of low to minor complexity with appropriate supervision.
- Makes decisions to resolve minor/moderate problems in standard situations. Makes decisions within guidelines and policies.
- Understands the fundamental business drivers for the company. Uses this knowledge in own work.
- Ability to develop projects plans to support short-term operational goals and contribute to the development of global regulatory initiatives with appropriate supervision.
- Postgraduate in Pharmacy or equivalent Sciences degree.
- Candidate is required to have a basic understanding of manufacturing / pharmaceutical sciences / the pharmaceutical industry with an understanding of drug development/commercial manufacturing of pharmaceutical products with technical writing skills.
- Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to support others in system use.
Work Location Assignment: Flexible
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