Regulatory Affairs Manager – Permanent
Bio-Pharmaceutical sector
Remote
Salary – £60k – £65k + up to 20% annual bonus, private healthcare etc.
THE ROLE…
- To manage all attributes of regulatory affairs and regulatory compliance for the Company’s licensed products
- Manage the evaluation of the regulatory impact of post-marketing activities such as projects or proposed manufacturing changes and to ensure continued compliance with regulatory licences.
- Represent the Regulatory function on multi-disciplinary teams for licensed products with regard to projects and proposed post-marketing changes.
- Ensure that the regulatory strategy is aligned with project and business objectives and that deliverables are on time.
- Supervise the preparation and maintenance of submission documents in support of licensed products (e.g. supplements, variations, annual reports, meeting requests, general correspondence, responses to inquiries from regulatory agencies). Involves the collection, review and assembly of scientific, medical, manufacturing, and other supporting documentation into submission documents.
- Manage local submission tracking and document control activities.
- Represent the Regulatory function at Change Control Review and CAPA Boards as required.
- Support regulatory impact assessment in support of quality events relating to licensed products.
- Provide regulatory support to commercial contract manufacturing facilities; liaise with contract manufacturers and regulatory contractors and partners on an as needed basis.
- Support manufacturing site compliance by managing the maintenance of the relevant Site Master Files and site manufacturing licences.
WHAT YOU WILL NEED..
- Educated to degree or equivalent level in a life science subject.
- Background in Regulatory CMC with a particular focus on Biologics/Biotech products.
- Demonstrated knowledge of MHRA, Health Canada and FDA regulations
- Excellent negotiation skills in dealing with third parties and internal stakeholders.
BENEFITS…
- 25 holidays + bank holidays and 3 annual company closure days (to be taken between Christmas and New year)
- Competitive Pension Scheme
- Private Medical Insurance
- Discretionary Bonus Plan
- Paid Maternity and Paternity Leave
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