Regulatory Affairs Manager

Job Ref: J23886
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 09 October 2017
  • West London, London, England, UK
  • Competitive
  • Natasha Rollason

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The Role:

The Regulatory Affairs Manager is responsible for the lifecycle management of key EU Post approval activities, ensuring smooth integration of new products following launch with all associated post approval activities.

This would include Strategy planning, Communicating with internal Stakeholders and Health Authorities, ensuring Regulatory submissions are to the highest quality, compliant and in line with the business timelines.

Responsibilities

Maintain up to date knowledge of relevant regulations and guidelines, and propose strategies for effective implementation, knowledge sharing and advice to project teams

Implement agreed regulatory strategies to plan, anticipate and resolve roadblocks, escalate issues through effective communication

Proactively communicate with relevant internal stakeholders and external contacts, e.g. partners, and induce a trustful working relationship to ensure regulatory requirements for submissions are met and approvals expedited

Ensure preparation, submission, approval and maintenance of high quality documentation, following current best practice standards

Provide expert advice and support to brand teams and other areas of the business

Provide input into the budgeting process e.g. relating to regulatory fees and CRO support required for prospective regulatory submissions

Manage own workload to ensure agreed regulatory timeframes are met, and propose solutions to own manager if resource constraints

Manage, coach and mentor peers and direct reports, if applicable, to deliver business objectives, ensuring their continued personal development

Maintain data and documentation in compliance within regulatory systems and procedures

Experience / Qualifications

Life Sciences Qualified.

Extensive EU Regulatory Affairs experience within Life Cycle management via MRP, DCP, and CP

Considerable regulatory experience with AU and NZ MAA and LCM regulatory requirements and processes

Ability to analyse and interpret complex issues, and develop and communicate strategies and plans to resolve

Seeks and accepts responsibility to enhance overall business performance

Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook

Able to contribute to budget preparation and review

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.