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Regulatory Affairs CMC/ Senior Manager. As a Regulatory Affairs, CMC lead for developing programs. A great opportunity to demonstrate your knowledge in leading regulatory processes for products across the globe, with a focus on oncology and neurology.

Lead and manage CMC-regulatory activities across various development and marketed products, ensuring compliance and regulatory risk mitigation. Develop and execute CMC-regulatory strategies and oversee the preparation of key regulatory documents, including Module 3 sections. Senior Manager, CMC-Regu

Define and implement CMC regulatory strategies for assigned projects and products. Contribute to patient-centric initiatives by proposing regulatory approaches aligned with healthcare values. Prior engagement with regulatory agencies, including briefing document preparation and participation in agen

Coordinate with affiliates and distributors in emerging markets to address CMC regulatory matters. Contribute to patient-centric initiatives by proposing regulatory approaches aligned with healthcare values. Provide regulatory support for established products, including submissions in growth markets

Conduct global regulatory surveys and assist in preparing regulatory reports for internal and external stakeholders. Proven experience in policy drafting, regulatory monitoring, and compliance audits. Draft, amend, and implement regulatory policies and internal compliance guides.

Lead and manage CMC-regulatory activities across various development and marketed products, ensuring compliance and regulatory risk mitigation. Develop and execute CMC-regulatory strategies and oversee the preparation of key regulatory documents, including Module 3 sections. Senior Manager, CMC-Regu

Mantell Associates is currently partnered with an exciting Biomedical Research organisation, who are looking to bring in a Global Regulatory Affairs Senior Manager to take the company to new heights as they continue to grow. Senior Manager Global Regulatory Affairs - Responsibilities:. Manage extern

Regulatory Affairs CMC/ Senior Manager. Change Control assessment experience (application of relevant regulatory guidance to proposed change). This is an exciting opportunity to demonstrate your knowledge in managing regulatory processes from authoring CMC sections for developing biological/Small Mo

As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services. Experience : 5 years in Medicinal Products Regulatory Affairs with 2 years in Project Management. Global Regulatory Teams (GRT) management o