Head of Regulatory Affairs (m/w/d)

CHEPLAPHARM; Greifswald; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A global pharmaceuticals leader is seeking a Head of Regulatory Affairs based in Greifswald, Germany. This role involves leading a product team, managing regulatory processes, and ensuring compliance with legal requirements. The ideal candidate has over 10 years of experience in Regulatory Affairs, with strong leadership and communication skills in both German and English. Benefits include flexible working models, a diverse corporate culture, and ample professional development opportunities.

Leistungen

Flexible working models & work-life balance

Access to corporate benefits platform

Internal and external training courses

Qualifikationen

• At least 10 years of professional experience in Regulatory Affairs.
• Initial leadership experience is an advantage.
• Confident communicator in German and English, both written and spoken.

Aufgaben

• Lead regulatory activities of a product team.
• Manage regulatory processes and risk effectively.
• Support cross-functional projects and process optimization.
• Act as the Regulatory Affairs representative in initiatives.
• Monitor legislative and regulatory developments.
• Provide strong technical leadership to the team.

Kenntnisse

Regulatory Lifecycle Expertise

Stakeholder & Interface Management

Communication & Negotiation Skills

Team Orientation

Ausbildung

Degree in Natural Sciences, Pharmacy or Medicine

Jobbeschreibung

Head of Regulatory Affairs (m/w/d) – CHEPLAPHARM

We are an owner‑managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be the sustainable platform for long‑established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research‑based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market. This benefits our partners and patients worldwide. Over the past 20 years we have become one of the world’s leading companies in the acquisition of original preparations, and we continue to grow with approximately 800 employees striving to ‘ACHIEVE MORE’.

The Regulatory Affairs department is structured into three Business Units – Regulatory Affairs, CMC and Regulatory Operations. Within this setup the Regulatory Affairs team is a dynamic international group of 69 colleagues, consisting of a Director, five Heads and a Regulatory Affairs Manager. Together, the team ensures sustainable regulatory compliance across key markets and supports the successful lifecycle management of our products by working closely with health authorities, regional partners and internal stakeholders worldwide.

Responsibilities

• Lead and Drive Regulatory Strategy
  Lead the regulatory activities of one product team with up to 10 team members and ensure compliance with all relevant national and international legal and regulatory requirements. Develop and implement the regulatory strategy in line with company objectives and product lifecycle needs.
• Own and Manage Regulatory Processes and Risk
  Take full responsibility for all regulatory processes within the team, ensuring timely execution and proactive risk management across the entire regulatory scope.
• Support Cross‑Functional Projects and Process Optimization
  Provide comprehensive regulatory expertise to internal functions and project teams (e.g. manufacturing transfers) and actively contribute to the continuous optimization of regulatory processes, systems and interfaces.
• Represent Regulatory Affairs Across the Organization
  Act as the Regulatory Affairs representative in cross‑functional initiatives, ensuring regulatory requirements are embedded in strategic and operational decision‑making.
• Monitor Regulatory Landscape and Business Impact
  Continuously monitor and assess legislative and regulatory developments and evaluate their impact and opportunities for CHEPLAPHARM.
• Lead, Develop and Empower the Team
  Provide strong technical leadership, foster professional development and ensure continuous growth and engagement of your team.
• Manage External Service Providers
  Effectively manage external service providers acting on behalf of CHEPLAPHARM, ensuring quality, compliance and performance.

Qualifications

• Academic Background & Regulatory Experience
  Successfully completed a degree in Natural Sciences, Pharmacy or Medicine, combined with at least 10 years of professional experience in Regulatory Affairs within national and international environments. Initial leadership experience is an advantage.
• Regulatory Lifecycle Expertise
  Strong understanding of multidisciplinary functions across the pharmaceutical product lifecycle and their regulatory interdependencies.
• Regulatory Strategy & Execution Excellence
  Proven experience in the development, coordination and leadership of national and international regulatory strategies.
• Stakeholder & Interface Management
  High level of competence in managing complex interfaces and engaging with internal and external stakeholders.
• Working Style & Team Orientation
  Cooperative, responsible and solution‑oriented working approach with strong team spirit, commitment and high‑performance motivation.
• Communication & Negotiation Skills
  Confident communicator and negotiator in both German and English, written and spoken.

Benefits

• Corporate culture & internationality
  A growing company with a diverse, open working environment and employees from around 40 countries.
• Flexible working models & work‑life balance
  Individually customisable working models, including the option to work from another EU country for up to two months per year, a working time account with compensatory time off and 30 days of holiday.
• Individual Benefits & Pension Provision
  Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs.
• Discounts & Additional Benefits
  Access to the corporate benefits platform with discounts at hundreds of partner companies.
• Further development & team culture
  Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.

We look forward to receiving your detailed application! Please only use the ‘Apply now!’ function to submit your application.

Seniority level: Director

Employment type: Full‑time

Job function: Legal | Industries: Pharmaceutical Manufacturing