We're looking to appoint a Head of Regulatory Affairs to lead a team of seven Regulatory professionals responsible for product marketing authorisations, registrations and submissions to ensure the supply of Fresenius Kabi licensed and unlicensed medicinal products, enteral nutrition and medical devices to UK and Ireland.

The jobholder will report directly to our Quality & Regulatory Affairs Director and will be a key member of their leadership team.

This role is based in Runcorn, Cheshire with the ability to work from home 1-2 days per week.

To develop and deliver regulatory strategy in line with Fresenius Kabi strategic objectives, enabling the timely launch of new products and the maintenance of our existing product portfolio across Great Britain, Northern Ireland and Ireland.

Develop, lead and support the regulatory affairs team ensuring that they are trained and appropriately skilled to fulfil their duties and provide a professional, responsive and efficient service to the business.

Lead and support the regulatory affairs team to ensure the following accountabilities are successfully fulfilled in line with the regulatory strategy:

• Regulatory submissions for licensed and unlicensed medicinal products are filed and approved for all post marketing authorisation applications.
• Initial Marketing Authorisation applications are filed and approved, liaising directly with global, regional and production unit regulatory colleagues along with the regulatory agencies to ensure local marketing authorisations are granted.
• Enteral Nutrition DHSC acknowledgements and ACBS submissions are filed and approved.
• Regulatory submissions for Fresenius Kabi AG medical devices and registration file maintenance.
• Promotional material is accurately reviewed against the current ABPI Code of Practice, relevant regulations, and other applicable guidance.
• Product labelling is compliant to current applicable legislation and work closely with global, regional, and local marketing departments to ensure that the local market needs are maintained.
• Change control regulatory assessments and regulatory approvals within QMS.

To act as the key point of contact for all branded price approval applications to the Department of Health and ensure that the quarterly returns are filed within required timelines.

Ensure local regulatory budgets are agreed with Region Europe and regularly reviewed to ensure that any potential deviations from the agreed budget are escalated.

Provide regulatory and vigilance advice and support with potential business risks and opportunities.

To act as a named responsible person for Fresenius Kabi Limited and Calea UK Limited for the controlled drug licenses and to ensure that all legislative requirements are met.

Ensure that all licenses, including specials license, ISO 9001 and medical device licenses are kept up to date.

Experience and Qualifications

Scientific qualifications (degree or equivalent)

Established Regulatory Affairs expertise with line management experience.

Excellent communication, project management and interpersonal skills.

Ability to build solid stakeholder relationship skills.

Strong team player with a dedication to embrace the Fresenius principles.

Benefits

• Private healthcare (including GP appointments)
• Annual objective bonus
• Contributory Pension Scheme (rises with service)
• Role specific tailored training and development plan
• Professional fees paid
• Life Insurance (4 x salary, death in service)
• 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays
• Maternity, Paternity and Adoption Leave
• Bike to work scheme
• Long Service Awards
• Employee Assistance Programme
• Blue Light Card
• Company funded family days out
• Volunteering policy

We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.