Job Description
Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 2,500 employees in 26 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!
Regulatory Affairs Manager (m/f/d) Labeling, Advertising and Promotion - EMEA & DACH
- You provide leadership for and manage regulatory aspects of the copy review/approval process for all promotional materials within the EMEA region and DACH, ensuring compliance of promotional materials and labeling for medical devices and medicinal products with laws, regulations and published guidance documents
- In addition to that, you provide guidance and expertise to internal stakeholders, as well as leadership team members and external stakeholders (including affiliates and agencies)
- You fulfil the deputy responsibilities of the German "Informationsbeauftragte*r" (pursuant to the German Drug Law §74a), including the full personal legal liability of every drug-related final promotional, scientific and labeling piece being distributed in EMEA and DACH
- You are responsible for reviewing and releasing artworks, promotional and scientific information for medicinal products while providing leadership and guidance on regulatory aspects in accordance with applicable law
- You ensure adherence and compliance to our review and release process
- You provide guidance and risk assessments on proposed claims for products in development and development of ISI (Important Safety Information) and brief summaries
- In close collaboration with the R&D project teams, you create launch materials for new products and indications
- You oversee the timely and accurate submission of labeling and promotional materials as needed
- Working closely with Legal, Medical Affairs, and Commercial business units, you improve and enhance the review process, establishing consistent best practices and submission guidelines
- You also contribute to the development and implementation of corporate policies and procedures for the regulation of labeling and promotional materials and other external communications/press releases
- You coordinate and implement training of Merz employees and external stakeholders on regulatory issues pertaining to promotion of company products
- Additionally, you regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement actions, in order to advise internal stakeholders on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales and Marketing and other product-related teams
- Pharmaceutical degree with approbation or in the absence of a pharmaceutical degree: a Natural scientific background (medicine, (human) biology, chemistry etc.), diploma, master degree or PhD with at least 5 years of pharmaceutical industry experience and a minimum of 2 years in regulatory affairs
- Strong knowledge of EMEA and DACH regulations and guidance, pertaining to drug and device advertising, promotion, and labeling
- Preferably experience with social media platforms and their use in the context of drug and device advertising, promotion, and labeling
- Proficiency in all MS Office applications
- Excellent verbal and written communication and presentation skills in German and English
- Strong attention to detail, the ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
- Excellent organizational, prioritization and planning skills and the ability to work independently on projects and initiatives internally and with external vendors
- Confidence and ability to influence key stakeholders
Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our different internal and external support systems.
Family and work: Our employees should be able to reconcile their family and work commitments. That's why you'll find, for example, company day care centers at our locations. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.
Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flex-working time and mobile working. Our employees also benefit from generous arrangements for annual leave.
Ongoing training: Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.
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