Category Regulatory Affairs Manager

Category Regulatory Affairs Manager

Perrigo

Multiple Locations

Scope of the Role

Strategic Regulatory Leadership

• Lead the regulatory lifecycle management of biocidal products, including licensing, renewals, variations, and post-marketing activities.
• Develop and implement regulatory strategies aligned with business objectives and evolving regulatory frameworks (e.g., BPR, REACH, CLP).
• Serve as the subject matter expert on biocides, providing strategic guidance to internal stakeholders and senior leadership.

Team Management & Development

• Manage and mentor the Biocides Regulatory Affairs team, fostering a culture of accountability, collaboration, and continuous improvement.
• Set clear objectives, monitor performance, and support professional development within the team.

Cross-Functional Collaboration

• Partner closely with cross-functional teams including R&D, Quality, Supply Chain, Commercial, and Legal to ensure regulatory alignment and support product development and market access.
• Actively contribute to regulatory input in innovation projects, product launches, and strategic business initiatives.

Technical Excellence

• Prepare, review, and submit high-quality regulatory dossiers for active substances and product authorizations under the Biocidal Products Regulation (EU BPR).
• Maintain up-to-date knowledge of EU and international regulatory requirements for biocidal products, including emerging trends and legislative changes.
• Ensure regulatory compliance across all relevant markets and proactively manage regulatory risks.

Experience Required

• University degree in Chemistry, Biology, Pharmacy, or related scientific discipline; advanced degree preferred.
• Minimum 5 years of experience in Regulatory Affairs, with a strong focus on biocidal products and chemical regulations.
• Proven experience in preparing and submitting dossiers under BPR, REACH, and CLP.
• Demonstrated leadership experience, including team management and stakeholder engagement.
• Strong understanding of regulatory frameworks across EU and global markets.
• Excellent project management skills with the ability to manage multiple priorities and deadlines.
• Fluent in English; additional European languages are a plus.
• Strategic thinker with a hands-on approach and a passion for regulatory excellence.
• Strong interpersonal and influencing skills, with the ability to build trust and drive alignment across diverse teams.
• Detail-oriented, analytical, and solution-focused.
• Resilient and adaptable in a dynamic regulatory and business environment.
• Committed to continuous learning and professional growth.