Mantell Associates is currently partnered with a market leading Pharmaceutical organisation on their search for a Head of R&D to be part of the site's leadership team.

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Regulatory Affairs Manager - Responsibilities:

• Review and approve technical reports written in support of regulatory submissions

• Review validation documentation including manufacturing process protocols and master batch records, as well as technical documents and reports (such as review development reports)

• Provide guidance/consultation for the preparation of various sections (with an emphasis on the CMC section), to insure successful regulatory filings in compliance with Regulatory agency requirements

• Plan meetings with regulatory agencies and lead on regulatory activities, including the management of authoring, review, and coordination of submissions

• Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans to gain alignment with team members, line management, and multiple stakeholders

• Develop innovative regulatory strategies that incorporates risk identification and mitigation

• Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions

• Oversee development of submission content, documents and timelines

• Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management

Regulatory Affairs Manager - Requirements:

• Bachelor’s Degree in Science discipline

• You must have strong experience with Regulatory Affairs

• Previous experience of dealing with regulatory agencies and FDA is a must

• Ability to work on problems of diverse scope

• Identifies priorities and key issues in complex situations and solves with minimal assistance

• Exercises judgement within generally defined regulatory practices and policies

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.