Applications from outside EU will not be considered

About the job

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team:

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

To Apply:

Please apply to this job post or you can visit our Careers page for more openings

Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Title: Regulatory Affairs Specialist / Sr. Regulatory Affairs Specialist

Location: EU / UK

Key Skills: Cosmetics Regulatory Affairs

• Fluent in English; additional proficiency in German or French or Italian or Dutch

Job Overview:

We are seeking aRegulatory Affairs Specialistto support comprehensive regulatory activities, including compliance, innovation, and audit preparedness for multiple European markets. This role demands expertise in managing product registrations, lifecycle management, and regulatory assessments while contributing to process improvements and operational efficiency. Candidates should be equipped to handle multi-market responsibilities and bring a strong understanding of the European regulatory landscape for cosmetics and personal care products.

Key Responsibilities:

Regulatory Compliance & Documentation:

• Manage product lifecycle activities, including renewals, variations, notifications, and new license applications across EU markets.
• Compile and maintain high-quality documentation for submissions, registrations, and product dossiers.
• Ensure timely resolution of regulatory queries and track outstanding documentation with authorities.
• Maintain and update ingredient archives, product registrations, databases, and tracking tools.
• Conduct regulatory assessments, including label, packaging, and formula reviews, to ensure compliance with EU regulations and market requirements.

Innovation, Advocacy, & Audit Preparedness:

• Contribute to advocacy activities by tracking regulatory trends and providing insights for strategic market actions.
• Assist with regulatory audit preparations by ensuring documentation and processes align with required standards.
• Support innovation efforts through ingredient and formulation assessments and guidance on compliance for new and existing products.

Regulatory Intelligence:

• Monitor Competent Authority websites and databases to stay updated on new regulatory requirements and guidelines.
• Conduct compliance risk assessments and recommend mitigation strategies for regulatory challenges.
• Provide timely updates and advisory on regulatory changes impacting multiple markets.

Multi-Market Coordination:

• Handle regulatory activities across markets, including France, Belgium, Germany, Italy, and The Netherlands.
• Collaborate with internal and external stakeholders to streamline processes and meet project timelines.
• Act as a subject matter expert for assigned regions and support knowledge transfer initiatives.

Process Optimization:

• Identify gaps in compliance workflows and recommend process improvements to enhance efficiency.
• Utilize regulatory tools and databases to streamline operations and ensure regulatory deliverables are met.

Qualifications:

• Education:Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Cosmetology, or a related field.
• Experience:Minimum 5 years in Regulatory Affairs for cosmetics, personal care, or similar FMCG industries.
• Strong knowledge of EU cosmetics regulations, including labeling, claims substantiation, and product compliance.
• Familiarity with regulatory processes in key markets: France, Belgium, Germany, Italy, and The Netherlands.

Skills & Competencies:

• Expertise in managing regulatory submissions, dossiers, and compliance activities.
• Strong cross-functional coordination and stakeholder management abilities.
• Proficient in using regulatory tools, databases, and software (e.g., DMS, MS Office, regulatory portals).
• Analytical and detail-oriented with the ability to prioritize and handle multiple markets simultaneously.
• Fluent in English; additional proficiency in German, French, Italian, or Dutch is highly desirable.

Additional Information:

• This is a remote role requiring collaboration across time zones. Occasional travel within Europe may be needed.
• Candidates with experience in innovation and regulatory intelligence will be preferred.