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
This Organisation are offering a competitive salary and excellent benefits
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Oliver Wood on +44 2038 547700.