Senior Manager Regulatory Affairs

Job Ref: J30241
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 22 January 2019
  • London, England, UK UK Sl3 6ez
  • £55,000 - £70,000 per Annum
    ANNUM
  • Neal Panting
  • 01753 589601
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Regulatory Affairs Senior Manager. The role will be based at my client's offices in Central London.

The Role:

The Regulatory Affairs Snr Manager provides regulatory support and expertise on assigned programmes, and is responsible for specific pieces of moderately complex projects. In addition, the Regulatory Affairs Snr Manager reviews scientific documents intended for submission to regulatory authorities in the International Regions.

Key Responsibilities:

Assists with the planning and preparation of submissions to regulatory authorities, with minimal supervision

Independently solves problems of moderate complexity and scope, with limited supervision

Determines the best and most appropriate methods and procedures on new assignments independently

Applies knowledge of regulatory requirements to the review of scientific documentation and supporting country specific documents intended for submission to regulatory authorities

Analyses new regulations and guidelines and makes process improvement recommendations to group

Prepares and delivers effective presentations for department meetings

May represent Regulatory Affairs department on assigned project sub-teams and/or task forces, with supervision

Skills and Experience required:

BSc. Advanced scientific related degree preferred;

Experience in preparation and submission of documentation for Global agencies; such as CMPs/CPPs, MAAs, variations, PSURs including country specific requirements.

Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations

Displays sound project management skills

Exercises good judgment within defined procedures and practices to determine viable solutions

Demonstrates advanced knowledge and understanding of applicable regulations

Speaking a second European language is desirable.

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 589626

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.

SRG
21/02/2019 15:38:27
GBP 55000.00 55000.00.