Regulatory Submissions Officer

Job Ref: J28302
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 04 September 2018
  • Wimbledon, London, England, UK
  • £1 per Annum
  • Neal Panting
  • 01753 589601

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The role:

Responsible for collation and maintenance of regulatory product information. Assisting in managing, maintaining and preparing registrations/notifications for UK, Ireland and the Emerging Markets to ensure product compliance in various categories including herbal, homeopathic, food, food supplement and cosmetics. Supporting the UK and global regulatory teams. Working with the UK marketing team and support the global marketing teams to ensure advertising and marketing communications are compliant. Major Duties and Responsibilities:* Collating of data and preparation of dossiers for submission to Regulatory Authorities (UK and Overseas/Emerging Markets). Close liaison with regulatory authorities. Co-ordination of follow-up with Regulatory Authorities so that Marketing Authorisations (MA) are received in a timely fashion.* Support in maintaining existing MAs (variation, renewals, PSURs) & update safety information.* Artwork review and provision of regulatory advice for marketing and sales functions for UK, Ireland and Emerging Markets, including: approval of product labelling and approval of advertising and promotional material in accordance with the legislation and best code of practice.* Provide support to Marketing, R&D & Supply Chain colleagues to help deliver projects* Attendance at internal and external meetings as required* Assist in co-ordinating technical information and producing templates for use by customer services and other departments.* Support the R&D team with routine stability protocol approval.* Contribute to the effective administrative organisation and running of the Regulatory Affairs department.Requirements/Qualifications:* Life Science Degree qualified.* Experience of working within the pharmaceutical/ healthcare industry in regulatory affairs.* Experience of regulatory review and compliance of marketing, communication and advertising material essential.* Professional, bright, ability to work on own initiative, self-motivated.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.

04/10/2018 09:25:30
GBP 0.00 0.00.