Regulatory Affairs Manager

OverviewJob Title:

Regulatory Affairs Team Lead (UK/EU)

Job Type:

Full-time, Permanent

Remuneration:

Up to £70,000 + 7.5% Bonus

An opportunity working for a growing speciality pharmaceutical business that focuses on CNS products and hospital injectables as a Regulatory Affairs Team Lead/Manager. The role reports to the Director of Regulatory Affairs.

This role is ideal for someone with a strong understanding of regulatory frameworks, excellent attention to detail, and the ability to work cross-functionally to support product development and approvals. You will manage a team of 3 officers.

This role plays a pivotal part in driving regulatory support for EU operations, contributing to company financial targets and growth. It includes harmonising regulatory efforts for EU products of the UK portfolio, with MAH under UK portfolio while regulatory oversight remains with UK team post-Brexit.

Additionally, supports in-licensing and acquisitions across UK and EU by collaborating with BD. Provides essential support for new product development initiatives and geographic expansion in UK and EU by aligning with commercial strategies.

Maintains a diverse portfolio of in-house manufacturing and contract manufacturing organisations for UK and EU, ensuring regulatory compliance and overseeing product lifecycle management.

Day-to-day responsibilities

Portfolio Management : Specialise in managing regulatory affairs for EU products within the portfolio, ensuring adherence to regulations and standards.

Gap Analysis : Assess Marketing Authorisation vs manufacturing documents to identify discrepancies.

New MA Applications : Lead preparation and submission of new MA applications in the EU via National, Mutual Recognition, and Decentralised Procedures.

Geographical Expansion : Drive expansion into other EU markets by navigating regulatory requirements.

RA Support for New Product Development : Provide regulatory guidance to ensure EU compliance from outset.

In-licensing Support : Regulatory support for in-licensing activities, integrating acquired products.

MA Compliance Maintenance : Ensure ongoing compliance and maintenance of MA for assigned portfolio and oversee team.

Safety Variations : Ensure safety variations in line with reference products, PRAC recommendations, and internal updates; oversee team submissions.

Change Control Management : Manage regulatory change controls, CAPAs, deviations; SAP familiarity preferred.

Implementation of PILs and Mock-ups : Oversee PILs and mock-ups implementation, finalising procedural aspects, national phases, artwork coordination.

Skills/Experience

Experience in the pharmaceutical industry, minimum 8 years.

Experience in a global matrix organisation and collaboration with external authorities and partners.

Mutual Recognition and Decentralised Procedures.

Philosophy that Regulatory Affairs is value-adding, not a bureaucratic function.

Commercial sense with commitment to high regulatory standards.

Planning, analytical and decision-making abilities with strategic vision and results-orientation, attention to detail.

Salary note: competitive salary up to 75k.

25 days annual leave, rising to 30 with length of service + bank holidays (prorated).

Holiday Buy/Sell – up to 5 days.

7.5% Bonus – discretionary scheme (policy eligibility).

Bravo Benefits Platform with discounts, wellbeing support, and more.

Salary Sacrifice for Electric vehicles with Tusker (policy eligibility).

Private Healthcare with Medicash health cash plan.

Working hours

Monday - Friday 37.5 hours per week, hybrid role.

This role does not offer sponsorship; you MUST be based in the UK and hold full right to work. You MUST be able to get to the site 3x per week.

For more information, please reach out to lucy.kirkaldy@cpl.com

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Science, Product Management, and Quality Assurance

Industries

Pharmaceutical Manufacturing and Biotechnology ..... full job details .....