EU Biocides Regulatory Lead — Strategy & Dossier Expert

ecolab

Kraków

Hybrid

PLN 180.000 - 240.000

Vollzeit

Vor 5 Tagen
Sei unter den ersten Bewerbenden

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Benefits dieser Stelle

Hybrid work model
Relocation support
Learning & development
Private medical care
Stock purchase

Zusammenfassung

Ecolab in Kraków, Poland seeks a Senior Regulatory Specialist (f/m/d) to lead EU biocidal product authorizations. You will develop regulatory strategies, manage cross-functional projects, and prepare EU dossiers defending submissions to authorities.

You’ll provide risk-based regulatory guidance, monitor EU legislation, and advise on business impact to support growth. International collaboration across Europe strengthens portfolio access and compliance.

Qualifikationen

  • PhD or MSc in Natural or Life Sciences (e.g., Chemistry, Toxicology, Ecotoxicology or related discipline).
  • 3-5 years of experience with the Biocidal Products Regulation (EU) 528/2012 and/or other European chemical regulations such as REACH.
  • Proven project leadership experience in a regulated environment with a strong track record of delivering complex regulatory projects.
  • Strong stakeholder management, influencing, communication, and collaboration skills.
  • Ability to manage ambiguity and complexity while providing pragmatic, business-oriented regulatory solutions.
  • Strong analytical, problem-solving, and organizational skills with the ability to prioritize competing activities effectively.
  • Strategic mindset and ability to assess the business impact of emerging regulatory developments.
  • Fluent in English

Aufgaben

  • Develop and execute regulatory strategies for EU biocidal product authorizations and approvals, balancing compliance requirements with business objectives.
  • Lead cross-functional regulatory projects and coordinate internal stakeholders, external consultants, and business partners to ensure timely execution.
  • Prepare, submit, and defend EU authorization dossiers, including managing responses to regulatory authorities and supporting regulatory negotiations.
  • Provide risk-based regulatory guidance and recommend mitigation strategies to support business decision-making and commercial growth.
  • Review and ensure compliance of internal data, study reports, supplier agreements, and supporting documentation with regulatory and legal requirements.
  • Monitor, interpret, communicate, and implement changes to EU biocides legislation, guidance, and regulatory practices.
  • Provide regulatory intelligence, business impact assessments, and strategic recommendations to internal stakeholders.
  • Serve as a trusted regulatory advisor to business partners, supporting innovation, portfolio management, and market access initiatives.

Kenntnisse

PhD/MSc in Life Sciences
Project leadership
Stakeholder management
Regulatory strategy
Communication
Ambiguity management
Analytical thinking
Strategic thinking
English fluency

Ausbildung

PhD or MSc in Natural or Life Sciences

Jobbeschreibung

Ecolab in Kraków, Poland seeks a Senior Regulatory Specialist (f/m/d) to lead EU biocidal product authorizations. You will develop regulatory strategies, manage cross-functional projects, and prepare EU dossiers defending submissions to authorities.

You’ll provide risk-based regulatory guidance, monitor EU legislation, and advise on business impact to support growth. International collaboration across Europe strengthens portfolio access and compliance.

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