Category Regulatory Affairs Manager

Perrigo; Roma; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company based in Rome is seeking a Regulatory Affairs Manager to oversee regulatory strategy and execution for its biocidal product portfolio. The ideal candidate will have at least 5 years of experience in Regulatory Affairs, a strong background in chemical regulations, and possess excellent project management skills. This role offers a hybrid working model, competitive compensation, and opportunities for career development.

Servizi

Competitive compensation

Career development opportunities

Flexible working environment

Competenze

• Minimum 5 years of experience in Regulatory Affairs focusing on biocidal products.
• Proven experience with BPR, REACH, and CLP regulations.
• Strong understanding of EU and global regulatory frameworks.

Mansioni

• Lead regulatory lifecycle management for biocidal products.
• Manage and mentor the Biocides Regulatory Affairs team.
• Prepare and submit high-quality regulatory dossiers.

Conoscenze

Regulatory Affairs

Team Management

Project Management

Fluent in English

Strong interpersonal skills

Formazione

University degree in Chemistry, Biology, Pharmacy, or related field

Advanced degree preferred

Descrizione del lavoro

Description Overview

Perrigo is seeking a dynamic and experienced Regulatory Affairs Manager to lead regulatory strategy and execution for our biocidal product portfolio across multiple territories.

This role offers a unique opportunity to shape regulatory pathways, drive compliance excellence, and lead a high-performing team within a fast-paced, innovation-driven environment.

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 bi 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.

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Perrigo. Hybrid Working Approach

We love our offices and the setting they provide for in‑person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo