Biosecurity Regulatory Manager

Il y a 1 mois

France Huvepharma Temps plein

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 alignm