Please login/register to apply for this job.
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.

PharmiWeb.jobs

 

 

Click Here To Apply!

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

Endless.

499 total views, 1 today

Apply for this Job