Please login/register to apply for this job.
6 Nov
2022
Contract Regulatory Affairs Manager
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
499 total views, 1 today