Job Title: Regulatory Affairs Team Lead (UK/EU)

Job Type: Full-time, Permanent

Location: High Wycombe, Buckinghamshire, UK (Hybrid)

Remuneration: Up to £80,000 + 7.5% Bonus

An opportunity working for a growing specialty 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. Within this role, you will manage a team of 4 officers. Previous line management is a must as well as real technical expertise.

This role plays a pivotal part in driving regulatory support for EU operations, contributing significantly to achieving company financial targets and fostering growth. This position holds a critical responsibility in harmonising regulatory efforts for EU products of the UK portfolio, particularly post-Brexit, where the business's Marketing Authorisation Holder (MAH), while regulatory oversight remains under the UK portfolio team.

Additionally, this role actively supports in-licensing and acquisitions across the UK and EU regions by collaborating closely with the business development team. Furthermore, it provides essential support for new product development initiatives and geographical expansion efforts in both the UK and EU regions by maintaining a seamless alignment with commercial strategies.

Another crucial aspect of the role involves the meticulous maintenance of a diverse product portfolio of In-house manufacturing and Contract Manufacturing Organisations for both the UK and EU markets, ensuring ongoing compliance with regulatory requirements and overseeing product lifecycle management activities.

Day-day responsibilities

• Portfolio Management: Specialise in managing regulatory affairs for EU products within the portfolio, ensuring adherence to relevant regulations and standards.
• Gap Analysis: Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies.
• New MA Applications: Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures.
• Geographical Expansion: Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards.
• RA Support for New Product Development: Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset.
• In-licensing Support: Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio.
• MA Compliance Maintenance: Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team.
• Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations.
• Change Control Management: Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred.
• Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork.

Skills/Experience

• Experience in the pharmaceutical industry minimum 8 years.
• A science degree.
• Leadership and developing team’s minimum 4 years.
• Working in a global matrix organisation and collaborating at all levels including external authorities and partners.
• Mutual Recognition and Decentralised Procedures.
• Philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic “necessary” function.
• Commercial sense, combined with an absolute commitment to high regulatory standards.
• Planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail.

Benefits:

• Competitive salary (up to 80k)
• 25 days annual leave, rising to 30 with length of service plus bank holidays (prorated)
• Holiday Buy/Sell – an opportunity to buy or sell up to an additional 5 days of holiday
• 7.5% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
• Bravo Benefits Platform – offering a variety of discounts, financial support, My MindPal, wellbeing app, menopause support and more
• Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
• Private Healthcare with an additional Medicash health cash plan

Working hours information

• Monday - Friday 37.5hrs per week, hybrid role.

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

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