Regulatory Affairs Manager - Pharmaceutical

Posted 12 March 2023
Salary Negotiable
Discipline Life Science Consulting
Contact NameJack Smith

Job description

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.

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

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.