[ref. x39823617] Senior Regulatory Affairs Specialist - London

Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Galderma (U.K.) Limited

Senior Regulatory Affairs Specialist

Full time, London Euston. Hybrid working.

Core mission:

• As a business partner, drive local Regulatory Affairs priorities for medicinal products (POM, including biologic, P and GSL), and if applicable cosmetics and medical devices, in accordance with the regulations, including obtaining and maintaining marketing authorisations for assigned medicinal products for both the UK and Ireland.

Responsibilities:

• Provide strategic direction to the business, accountable for delivering project goals and aligning functional strategies with business needs. Ensure that progress of applications and changes to registered details are communicated to local, regional, and global stakeholders, as appropriate, with minimum delay.
• Develop and ensure execution of (innovative) regulatory strategies to obtain timely/accelerated approvals by MHRA and HPRA.
• In partnership with Global Regulatory Affairs, lead new Marketing Authorisation Applications (MAAs) for UK (including ACCESS Consortium and International Recognition Procedure applications) and Ireland. Compile local dossier parts.
• Ensure compliance with, and maintenance of, existing product licenses through submissions of variations, renewals, and safety updates (PSURs/PBRERs etc.).
• Support & facilitate launch of new products by collaboration with Marketing/Commercial, Supply Chain, Customer Services, Demand Planning / Production, Finance, Corporate, General Management and other stakeholders as needed e.g. Medical Affairs, Market Access, and Pharmacovigilance.
• Ensure review (in co-ordination with the responsible in-country functions) and approval of promotional and non-promotional materials, taking a consistent approach and ensuring their compliance/conformity with local regulations, published codes of conduct/practice and internal guidelines.
• Update artwork of local packaging materials, through the global tool (Veeva PromoMats), in a timely manner and ensure tracking of packaging modifications and implementation into production.
• Prepare, submit, and follow up applications to the MHRA and/or HPRA for export certificates.
• Develop and maintain effective working relationships with MHRA and HPRA.
• Keep abreast of (and communicate internally) relevant regulatory, industry, legislative, political and competitor activities to define business impact and to develop appropriate regulatory strategies for Galderma’s product portfolio.
• Shape the regulatory landscape via networking with agencies (contributing to industry consultations) and industry associations, driving an agenda to create an external environment in which our portfolio can thrive.
• Manage in-house regulatory files, documentation and Corporate electronic databases ensuring that all files are up-to-date and compliant, and ensuring effective retrieval (both electronic & paper filing).
• Contribute regulatory expertise in local health authority/GxP inspections.
• Ensure all company’s pharmaceutical products are registered in compliance with the applicable regulations.
• Adhere to the company’s global and aligned local standard operating procedures and work instructions, which are in accordance with current legislation.
• Support and train junior regulatory team members, where applicable.
• Undertake 'ad-hoc' regulatory duties from time to time as may reasonably be required by the company e.g. contribute to regional and global regulatory strategy and support the medical team in generating responses to medical information enquiries from healthcare professionals and members of the public etc.

• A strong understanding and hands on experience, as well as strategic, regulatory experience
• pre- & and post-approval
• with medicinal products (POM, P & OTC), at local affiliate level for UK and Ireland.
• Experience with initial MAAs for biologics preferred.
• Experience with ACCESS Consortium submissions beneficial.
• Experience with cosmetics beneficial.
• Experience with MHRA (and preferably HPRA) interactions e.g. regarding new product development, leading pre-submission meetings, and post-approval changes.
• In-depth understanding of the pharmaceutical industry across the UK and Ireland.
• Significant know-how of the post-Brexit regulatory environment.

Soft Skills:

• Cross-functional regulatory collaborator with ability to consistently deliver high quality ‘right first time’ documentation.
• High level of accountability and a 'can-do' attitude.
• Excellent attention to detail.
• Strong scientific background.
• Effective communication skills.
• Customer service/relationship management (including negotiation) skills.
• Patient/consumer focused.
• Project management skills.
• Dynamic multi-tasker.
• Proactive decision maker.
• Adaptive learner (continuous improver).
• Fluency in English (excellent written and spoken).