Regulatory Affairs Manager - Labeling (m/f/x) | Frankfurt | Pharma
In this position, you will provide strategic regulatory expertise and guidance to internal stakeholders during the review and creation of labeling, review of advertising, promotional and other related materials for assigned products (medical devices and medicinal products) to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team and must possess a thorough knowledge of regulations for advisement and promotional compliance, governing drugs, device and combination products.
What will your tasks as Regulatory Affairs Manager - Labeling be?
- Provide leadership for and manage regulatory aspects of labeling and the copy review / approval process for promotional material, ensure compliance of promotional materials and labeling for medical devices and medicinal products
- Provide guidance on proposed claims for products in development and development of ISI and Brief Summaries
- Coordination of labeling translations and approvals by local regulatory experts and manage the translation in the labeling database
- Work closely with Legal, Medical Affairs and commercial business units on improving and enhancing the review process, establishing consistent best practices and submission guidelines
- Work closely with R&D project teams to create launch materials for new products and indications
- Develop and maintain SOPs and processes for review, approval and submission of labeling and advertising materials
- Manage the regulatory aspects of reviewing regulatory submissions and communications with health authorities; oversee timely and accurate submission of labeling and promotional materials as needed
- University degree in pharmacy or related scientific discipline; PhD will be an advantage
- 2+ years' experience of working in Regulatory Affairs with advertising and promotional materials within a pharmaceutical company
- 5 years' experience of working in the pharmaceutical industry
- Good knowledge of EMEA regulations and guidance pertaining to drug and device advertising / labeling / promotion
- Fullfil the responsibilities of the German "Informationsbeauftragter" (pursuant to the German Drug Law §74a)
- Experience with social media platform and their use in the context of drug and device advertising would be a plus
- Proven ability to plan, coordinate and lead submission activities simultaneously
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization
- Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well-organised and self-motivated
- Fluency in German (at least C1) as well as very good English skills
Information about our client:
Our client is a leading pharmaceuticals & medical devices companies in europe. The company is more than 100 years old and it's more than 3000 employees are operating in 50+ countries. The diverse specialties of the company include medical aesthetics and neurotoxin therapy. The company is also active in research, development and distribution of further innovative products (innovative health, wellness and beauty).
I look forward to your application!