Head of Regulatory Affairs (m/w/d)
1. Greifswald
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 not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ACHIEVE MORE’.
Our 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 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. If you would like to contribute your regulatory expertise to this dedicated and ambitious team, we look forward to receiving your application!
What makes your day with us special:
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). 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.
What sets you apart:
Academic Background & Regulatory Experience
Successfully completed 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.
What we offer you besides the job:
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. 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.
Your contact person:
2. Nadine Gustke
3. Recruiter
4. nadine.gustke@cheplapharm.com
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