Head Regulatory, Safety

vor 6 Monaten

Mannheim, Deutschland Cooper Consumer Health Vollzeit

Requisition ID
- 222
- Job Family 1- Regulatory & PSRM
- Country 1- Germany
- Location 1- Hybrid
- About us
- Are you ready to join an exciting journey in the world of consumer healthcare?

**Cooper Consumer Health** is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) products with strong brands such as **Valdispert, Oenobiol, Excilor, Vitascorbol, Lashilé **and many more.

Join us as we embark on an exciting phase of growth, with ambitious plans to double our business in the next 3-5 years.

Today, we're currently in the midst of an exciting M&A project to acquire a large OTC portfolio. This strategic move will expand our footprint across key European markets such as France, Netherlands, Italy, Belgium, Spain and Portugal.

Through this strategic acquisition, combine with our historical footprint, the Group will continue to be a pioneer in the development, manufacturing, and distribution of a diverse array of over-the-counter products. With our large portfolio, which includes now many leading brands in their area, we cater to the needs of our consumers with unparalleled excellence.

At each of our markets, we operate with an entrepreneurial spirit, fostering a culture of accountability and empowerment at every level. Our 'global local' approach ensures that each of our local teams is empowered to thrive in their respective markets, supported by a network of global experts.

Our values are more than just words on a page - they're the guiding principles that drive everything we do. From our commitment to empowerment and ownership to our unwavering dedication to respect, transparency, and inclusiveness, we believe in doing good to do well.

If you're ready to be a part of this exciting journey, join us at **Cooper Consumer Health** and together, let's empower healthier lives
- Job description 1
- Head of Regulatory, Safety and Medical Affairs DACH will be responsible for establishing and maintaining regulatory, safety and medical affairs infrastructure to ensure relevant support in the region. They will also lead a team of 2 employees and lead some external resources.

**The Role**:

- Leads the DACH regulatory function and builds an infrastructure to ensure regulatory support in the region, for affiliates and distributors.
- Provides oversight of regulatory-related launch and marketing activities in the region.
- Provides regulatory leadership, strategic guidance and local execution for the entire portfolio which includes medicines, medical devices, food supplements, herbals, and cosmetics for the region.
- Leads the preparation of DACH-specific documents for inclusion in submissions and label extensions.
- Ensures that the company’s products remain in regulatory compliance
- Acts as the principal liaison with country Competent Authorities (e.g. BfArM) for original product approvals and maintenance, including negotiation and maintenance of labelling.
- Works closely with the global Regulatory Affairs team to develop and implement the global regulatory strategy for the company’s products.
- Acts as a medical expert and provides medical and scientific support to brand strategies, product claims and promotional and non-promotional materials.

**Experience and Professional Qualifications**:

- Established regulatory with substantial industry experience in the (EU) healthcare markets, ideally in the DACH markets
- Proven track record of directly leading the launch of new products through EMA procedures and national agencies.
- Ideally experience as QPPV (Informationsbeauftragter, Stufenplanbeauftragter (QPPV) Sicherheitsbeauftragter (Health & Safety)).
- Excellent leadership and team management skills.
- Hands-on experience in navigating the challenges of a constantly evolving landscape, showcasing resilience and strategic agility.

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