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Regulatory Affairs Manager

London - Central
70,000
Permanent
Regulatory Affairs

Compass Life Sciences are partnered with a leader in the generic pharmaceutical manufacturing and product development field supporting their search for their next regulatory affairs manager. The company is filled with brilliant minds boasting a young and dynamic environment directly manufacturing pharmaceutical products in the United Kingdom main base being in Switzerland.

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Compass life sciences are partnered with a leader in the generic pharmaceutical manufacturing and product development field supporting their search for their next regulatory affairs manager. The company is filled with brilliant minds boasting a young and dynamic environment directly manufacturing pharmaceutical products in the United Kingdom main base being in Switzerland. The company is going through a great period of growth with the company supplying products to wholesales, retail pharmacies and hospitals. The company have real passion about sharing in the success and growth within the company. Their range of generic and branded medicines includes prescription medicines used in primary and secondary care and covers a broad range of therapeutic areas.

  • Competitive salary (open to negotiation)
  • Annual Bonus (10% of your yearly salary in bonuses)
  • St. James's Place Pension Scheme
  • Private Health care and dental
  • Based in offices in Canary Wharf London (Flexible options)

Key responsibilities:

  • Actively review, strengthen, align and execute regulatory procedures across the UK business and ensure compliance with all regulatory and cGMP requirements.
  • Preparation of new product dossiers for submission to the MHRA as well as retaining and organising relevant licence documentation efficiently.
  • Completion of dossier reviews.
  • To maintain awareness of current regulations and guidelines associated with the product lifecycle.
  • To participate and support customer and/or Regulatory Inspections of the UK offices associated with GMP operation.
  • To act as the main of contact between the company and their current PV provider on matters relating to PV including, assisting with PSUR's, SDEA's and RMP's and general medical information.
  • Responsibility for the writing and upkeep of all documentation required for the granting and upkeep of Licenses necessary to legitimately trade prescription medicines within the UK as directed by the MHRA, and continuous liaison with the MHRA to ensure all the aforementioned SOP's are maintained in a fully compliant order.
  • Developing and executing a regulatory strategy for new products including having a direct input in the choice of portfolio extensions.
  • Reviewing regulatory documents such as manufacturing batch records, packaging batch records, analytical method, validation protocol and reports.
  • Compilation of all regulatory documents including all Modules for submission according to local requirements.
  • Keeping up to date with regulatory issues in drug development processes and working to eliminate or minimise regulatory barriers.
  • Responsible for deficiency replies received from agency.
  • Maintenance of database with regulatory submission and approval.
  • Proactively keeping up to date with Regulatory guidance.
  • Overseeing the due diligence process to thoroughly assess viable opportunities and continually evaluate an opportunity against criteria to determine “proceed/cease” decisions.
  • Cross collaboration with the internal and external team involved in the product launch process including Sales, Marketing, Medical, Quality, Finance and Supply Teams.
  • Deliver and lead a new Regulatory affairs team.

Person specifications and minimum requirements to be successful in this role:

  • Graduate level/PhD level or equivalent.
  • Experience in the Pharmaceutical Industry including significant regulatory experience.
  • At least 5 years of pharmaceutical industry experience including both new drug product registrations and lifecycle submissions.
  • Fluent English (oral and written).
  • In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
  • You must understand the impact of the regulatory environment and proposed environment and proposed changes which are likely to impact the business in the medium terms.

How to apply:
If you would like to be considered for the role, please send your CV to Abigail Humphrey at [email protected]. If you would like an informal chat about the role please call Abigail on: 023 923 16039.

Recommendations:
Compass Associates Ltd trading as Compass Life Sciences are acting as a recruitment consultancy for this permanent vacancy; we can offer up to £1000 worth of John Lewis/ amazon vouchers or to a charity of your choice for each successful recommendation that then goes on to be placed by compass life sciences.

Apply for the position of Regulatory Affairs Manager now with Compass Life Sciences

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