Manager / Senior Manager - Regulatory Affairs - Hertfordshire (Head Office)

Medical Affairs, Other

East Anglia, East Midlands, London, South East (Excluding London)

£Competitive

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Reference: 6837

A new opportunity has arisen for a world-leading, research-driven Pharmaceutical company. This highly-successful organisation is searching for a Senior Manager or Manager of Regulatory Affairs, to support the advancement of assigned projects and quality maintenance of our client’s products. The level of this role is dependent upon the successful candidate.

Essential Requirements:
Experience working within the Pharmaceutical marketplace
Ability to communicate across internal and external regulatory affairs departments
Exposure of CMC regulatory affairs supporting development, growth markets submissions or post-approval activities plus additional related experience (i.e., in Research and Development or Manufacturing, clinical marketed products, etc.), preferably including some broader industry experience
Working knowledge of both the formulation and analytical aspects of R&D in addition to the above regulatory experience
Working knowledge of the principles of chemistry to drug synthesis
Exposure to a number of pharmaceutical dosage forms (e.g. solid, liquid and parenteral dosage forms) including process validation
Educated to degree level

Role Responsibilities:
Assumes regulatory accountability for the CMC aspects of the projects/products goals and objectives
Provides oversight for the CMC components of all regulatory submissions (IMPDs, Module 3 for MAAs, amendments, variations, scientific advice briefing documents, CMC agency communications etc.) to ensure that quality documents are prepared in compliance with the applicable regulatory requirements
Engages in CMC sub-teams to plan, prepare and complete the CMC sections of major submissions
Leads responses to Health Agency CMC questions
Interacts with and influences external stakeholders
Accountable for the quality and compliance of CMC aspects of all submissions made by the company
To be a main contact point within the group within the EU, US and Japan, for communications relating to Quality/CMC issues
Supports regulatory strategy and manages timelines to meet project needs
Engages with patients’ reality socialisation human health care (HHC) activities

Role Specific Competencies:
Ability to express a scientific opinion clearly and concisely and to defend regulatory decisions under pressure
High organisational skills and time management
Confidence in dealing with Regulatory Authorities
Ability to manage multiple projects and multiple tasks
Ability to work in a matrix environment

Recruitment Process:
2 stage process

Package:
Highly competitive package + bonus/bens

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

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