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6 Nov 2022

Contract Regulatory Affairs Manager

Jeanne Anywhere

Job Description


DETAILS:

  • Full-time permanent position
  • Office based in Hertfordshire
  • Competitive package

THE ROLE:

  • Oversee and perform the necessary activities in order to maintain Client’s site licences.
  • Communicate with internal and external stakeholders on the status and requirements of all regulatory submissions, providing guidance on the documentation required in support of applications.
  • Collate and review documentation in support of the Company’s Marketing Authorisations prior to submission, ensuring supporting documents are ’right first time’ and manage priorities to meet business objectives.
  • Co-ordinate with the regulatory partners of customers to ensure Marketing Authorisation compliance. Manage life cycle/ post authorization changes for UK relating to CMC, Clinical, Safety and product information changes.
  • Inform the Head of Quality of any problems that could impact on the approval or maintenance of licence requirements (site and product) licences.
  • Identify and manage regulatory projects, setting up project plans to ensure that regulatory approvals are delivered and can be implemented on time.
  • Develop and maintain a detailed plan of all known regulatory activities for the company licences.
  • Process all Marketing Authorisations and variation applications in a timely manner and ensure that all responses to regulatory questions are undertaken in line with defined targets.

Full job description available on application

THE CANDIDATE:

  • Relevant degree in a Pharmaceutical or scientific discipline.

Experience

  • Minimum 2 years experience in a Regulatory Affairs role in the Pharma industry, including new product acquisitions, licence submissions and variations.
  • Experience in the use of the MHRA submissions portal.
  • Previous exposure to liaising with Regulatory Authorities, including the MHRA, in relation to licencing and inspections.
  • Extensive knowledge of the MHRA licencing submission process, including categorization of licence variations.
  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

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Job Categories: Marketing manager. Job Types: Contract. Salaries: 40,000 - 60,000 and 60,000 - 80,000.

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