Senior Regulatory Affairs Specialist for UK and Ireland in London

Senior Regulatory Affairs Specialist for UK and Ireland in London

London Full-Time 56700 - 69300 £ / year (est.) No working from home possible
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At a Glance

  • Tasks: Lead regulatory activities for innovative dermatology products in the UK and Ireland.
  • Company: Join Galderma, a global leader in dermatology with a focus on innovation.
  • Benefits: Gain exposure to local and global regulatory affairs with competitive rewards.
  • Other info: Collaborative environment that values diversity and personal growth.
  • Why this job: Make a real impact on product launches and patient outcomes in skincare.
  • Qualifications: 5+ years in Regulatory Affairs with a degree in Life Sciences.

The predicted salary is between 56700 - 69300 £ per year.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. 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.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. 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.

Main purpose of the role: As a business partner/enabler, lead local Regulatory Affairs activities for medicinal products, and as applicable medical devices and cosmetics, ensuring regulatory compliance and supporting product registration and lifecycle management across the UK and Ireland.

Key Responsibilities:

  • Lead regulatory activities for the registration and lifecycle management of Galderma products across the UK and Ireland.
  • Develop and execute local regulatory strategies in partnership with Global and Regional Regulatory Affairs.
  • Manage post-approval activities, including marketing authorisation transfers, variations, renewals, PSURs/PBRERs and changes to registered details.
  • Support the successful launch and continued availability of products, collaborating with Marketing, Commercial, Supply Chain, Medical Affairs, Pharmacovigilance and other relevant functions.
  • Review and approve promotional and non-promotional materials to ensure compliance with local regulations, industry codes and internal guidelines.
  • Coordinate local artwork and packaging updates through Veeva PromoMats.
  • Build and maintain effective relationships with the MHRA and HPRA, including regulatory submissions, pre-submission meetings and post-approval interactions.
  • Monitor regulatory, legislative and industry developments and assess their impact on Galderma’s portfolio.
  • Contribute regulatory expertise to health authority and GxP inspections and ensure compliance with applicable legislation and company procedures.

Skills & Qualifications:

  • Degree-level qualification in Life Sciences or a related scientific discipline.
  • Minimum 5 years of hands‑on Regulatory Affairs experience across pre‑and post‑approval activities.
  • Proven experience within a local affiliate environment covering both the UK and Ireland.
  • Strong experience with medicinal products, including POM and P/OTC products.
  • Demonstrated experience interacting with MHRA and HPRA, including regulatory submissions, pre‑submission meetings and post‑approval activities.
  • Strong understanding of the pharmaceutical regulatory environment across the UK and Ireland.
  • In‑depth knowledge of the post‑Brexit regulatory landscape, including the Windsor Framework and International Recognition Procedure (IRP).
  • Experience working in a multinational pharmaceutical environment and collaborating with global and regional teams.
  • Strong project management, communication and stakeholder management skills, with sound judgement, attention to detail and a proactive, collaborative approach.
  • Fluency in English.

At Galderma, we offer an opportunity to work with innovative dermatology products and treatments in a leading global company. The role provides broad exposure to local, regional and global Regulatory Affairs activities, with the opportunity to contribute directly to product launches, ongoing product availability and the growth of Galderma’s portfolio across the UK and Ireland.

If your application is successful and your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the Hiring Manager. The final step is a panel conversation with the extended team.

Our people make a difference. At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Senior Regulatory Affairs Specialist for UK and Ireland in London employer: Galderma Limited (UK)

Galderma Limited is an exceptional employer that fosters a dynamic and inclusive work culture, offering employees the chance to lead innovative social media strategies in the dermatological skincare sector. With a strong emphasis on professional growth, team collaboration, and a hybrid work model in the vibrant Greater London area, employees enjoy a comprehensive benefits package that supports their well-being and career development. Join us to make a meaningful impact in the beauty industry while working alongside passionate professionals dedicated to excellence.

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Contact Details:

Galderma Limited (UK) Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Senior Regulatory Affairs Specialist for UK and Ireland in London

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We think you need these skills to ace Senior Regulatory Affairs Specialist for UK and Ireland in London

Regulatory Affairs
Medicinal Products Knowledge
Post-Approval Activities Management
Marketing Authorisation Transfers
Variations and Renewals Management
Collaboration with Cross-Functional Teams
MHRA and HPRA Interaction

Some tips for your application 🫡

Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Galderma Limited (UK)!

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How to prepare for a job interview at Galderma Limited (UK)

Understand the Science

Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Galderma Limited (UK) that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.

Showcase Relevant Experience

If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.

Know Their Products

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Be Ready for Regulatory Scenarios

In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.