Biosecurity Regulatory Manager

Huvepharma; France; Hybride; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A multinational biosecurity firm is looking for a Senior Regulatory Affairs Manager to oversee compliance with EU Biocidal Products Regulation. This role involves independent management of regulatory projects and collaboration across international teams. The ideal candidate will have strong expertise in EU BPR, proven people management skills, and will be responsible for strategic regulatory decisions affecting the company’s biosecurity products portfolio. Fluent English and a Master’s degree in Life Sciences are required.

Qualifications

• Hands-on expertise in EU BPR, including biocidal product authorisations.
• Strong knowledge of ECHA processes and regulatory pathways.
• Proven experience managing complex regulatory projects.

Responsabilités

• Define and implement the International Biosecurity strategy.
• Lead preparation, compilation, and submission of authorisation dossiers.
• Provide expert oversight of scientific and technical data for BPR dossiers.

Connaissances

Expertise in EU BPR

Regulatory project management

Stakeholder management

Communication skills

Team leadership

Formation

Master’s degree in Life Sciences or related field

Description du poste

Senior Regulatory Affairs Manager – Biosecurity (EU BPR Expert)

Preferred Location: France (flexible remote working; nearby European countries may be considered)

Reporting to: Business Director Biosecurity

Scope: Europe (EU BPR) and selected International Markets

About the Role

We are seeking a Senior Regulatory Affairs Manager – Biosecurity with strong and proven expertise in the EU Biocidal Products Regulation (BPR – Regulation (EU) No 528/2012) to support, secure, and expand our international biosecurity and hygiene product portfolio.

This position is part of a team of experienced managers with diverse cultural and professional backgrounds, operating across multiple countries and functions. The successful candidate will be comfortable working in a highly international and distributed environment, where collaboration is frequent despite geographical distance, and where colleagues share common values, high standards, and a strong sense of collective responsibility.

The role requires a high level of autonomy, accountability, and maturity, combined with a strong team-oriented mindset. The successful candidate will be expected to work independently on complex regulatory matters while actively contributing to collective decision-making, information sharing, and mutual support.

Based preferably in France, with flexible remote working possible, this role ensures close collaboration between Regulatory and Production headquarters, Commercial and Marketing teams, and key subsidiaries, notably the French entity. Candidates located in nearby European countries may also be considered.

The position reports to the Business Director Biosecurity and includes direct people management responsibility for one Regulatory Affairs professional.

Key Responsibilities

1. Biosecurity Regulatory Strategy

• Define and implement our International Biosecurity strategy with a specific focus on EU BPR for biosecurity and hygiene products in alignment with global business objectives.
• Secure and maintain the company’s portfolio of existing biocidal product authorisations across International + EU markets.
• Assess regulatory feasibility of new products, formulations, and claims (Go/No-Go), considering regulatory risk, timelines, and cost.
• Monitor the approval, renewal, and review status of active substances, and evaluate impact on current and future products.
• Anticipate regulatory risks and proactively propose mitigation and contingency strategies.

2. Registration, Authorisation & Lifecycle Management

• Lead the preparation, compilation, and submission of biocidal product authorisation dossiers under:
• National Authorisations
• Mutual Recognition (MR)
• Union Authorisation (UA)
• Manage post-authorisation activities, including variations, renewals, administrative changes, and ongoing compliance obligations.
• Coordinate, compile, and defend responses to Competent Authorities and ECHA, providing scientifically robust and business-oriented arguments.
• Ensure consistency between authorised conditions, product formulations, labels, and market claims throughout the product lifecycle.

3. Scientific, Compliance & Regulatory Intelligence Oversight

• Provide expert oversight and critical review of scientific and technical data required for BPR dossiers, including efficacy, toxicology, and environmental risk assessments.
• Coordinate data generation with Regulatory HQ, Production HQ, R&D, Quality (QC/QA), and external partners.
• Ensure regulatory compliance of labels, SDS, technical documentation, and marketing materials, with operational execution delegated where appropriate.
• Monitor and interpret EU and national regulatory developments related to BPR and ECHA guidance, and assess impact on the portfolio.
• Maintain active interactions with Competent Authorities, ECHA, consultants, and industry associations.

4. Budget Ownership & Financial Responsibility

• Define, manage, and monitor the regulatory budget for Biosecurity activities, in close collaboration with Finance and headquarters.
• Evaluate, negotiate, and approve quotations, contracts, and invoices related to regulatory submissions, studies, CROs, and consultants.
• Ensure financial visibility, cost efficiency, and alignment with portfolio priorities.
• Contribute to medium- and long-term regulatory cost forecasting.
• Directly manage and develop one Regulatory Affairs professional, primarily responsible for international (non-EU) registrations and operational regulatory activities.
• Set priorities, delegate effectively, and ensure quality and consistency of regulatory outputs.
• Encourage autonomy while providing guidance, coaching, and regulatory oversight.
• Act as the regulatory biosecurity reference across the organization.
• Ensure effective collaboration between:
  • Regulatory and Production headquarters,
  • Commercial and Marketing teams,
  • Key subsidiaries, especially the French entity.
• Translate regulatory constraints into clear, pragmatic guidance for non-regulatory stakeholders.
• Contribute to a trust‑based, collaborative team culture, valuing open communication, shared responsibility, and collective success.

Profile & Qualifications

• Master’s degree (Bac+5) in Life Sciences, Chemistry, Toxicology, Environmental Sciences, Biotechnology, or equivalent.
• Proven, hands‑on expertise in EU BPR, including biocidal product authorisations and lifecycle management.
• Strong knowledge of ECHA processes, national Competent Authority requirements, and regulatory pathways (NA, MR, UA).
• Experience in biosecurity, disinfectants, hygiene products, or related sectors is highly desirable.
• Demonstrated ability to manage complex regulatory projects and budgets independently.
• Experience in people management or functional leadership, including effective delegation and coaching.
• Strong stakeholder management, communication, and influencing skills.
• Demonstrated maturity and ability to work autonomously while thriving in a collaborative, international team environment.
• Fluent in English; French is a strong asset. Additional languages are a plus.