Director Regulatory Affairs Germany & Austria (m/f/x) | Frankfurt | Consumer Health Care
In this role, you will be leading the Regulatory Affairs team in the cluster and manage the team members and the external service providers to achieve superior team results while developing and implementing the regulatory strategy in the cluster to support successful local approvals, maintaining Marketing Authorizations, and ensuring regulatory compliance for Consumer Health Care products. Additionally, you will be giving strategic input into regional projects to meet business objectives.
What will your tasks as "Director Regulatory Affairs Germany & Austria" be?
- To ensure compliance of the cluster PHC portfolio to applicable regulations, guidelines, and company standards, covering medicinal products, foods (mainly food supplements), medical devices and cosmetics.
- Ensure timely regulatory submissions, renewals, assessments, and decisions/approvals based on priority and work plan in the countries of responsibility.
- Proactively share up-to-date regulatory insights, intelligence and trend analysis to drive greater business competitive advantage. Highlight to the organization any potential risks or opportunities to the business.
- Ensure the conformity of the product artworks, promotional material and tools with the marketing code, legal requirements and within current marketing authorisations.
- Close collaboration with the commercial multifunctional teams, with medical, pharmacovigilance and quality functional groups within the cluster.
- Review and monitor RA Cluster budget and related expenses.
- To liaise with health authorities, distributors, regulatory authorities, trade associations and contract manufacturers in the region, in order to achieve and maintain registrations in countries of responsibility.
- To develop relationships with regulatory and industry bodies in order to represent the interests of the organization, gain relevant information and help shape change.
- Support business in the assessment of new ideas and set up and implement the Regulatory strategy for new product registrations and variations in collaboration with other Regulatory teams and further involved departments
- Develop the capabilities of RA team members to ensure competency and currency of knowledge to deliver/exceed the RA services needed for the business.
- Engage with and represent the Regulatory function in the DAT leadership team and ensure regular connect with other countries commercial Leaders
- Serve and contribute as local Regulatory expert to all activities of a pharmaceutical business where such expertise and input is required
- Accurate maintenance of Corporate Systems and Databases for products information, data and documentation
- Drive opportunities to streamline processes and successfully build organizational alignment. Lead RA department systems initiatives.
Your requirements as "Director Regulatory Affairs Germany & Austria"?
- University degree in pharmacy or related scientific discipline; PhD will be an advantage
- 8+ years' experience in a hands-on Regulatory Affairs role for either pharmaceuticals, OTC, foods, consumer health care or cosmetics
- 3+ years' experience in a people management / leading role
- Experience in working in a Matrix structure and ideally ability to lead remotely
- Ability to understand business needs, think strategically and develop risk mitigation strategies
- Excellent German and English communication skills (oral and written); Ability to communicate effectively in English to convey complex technical information ro regional and global area experts
- Excellent communication skills, flexibility and perseverance as well as strong intercultural competencies
Information about our client :
Our client was founded over 150 years ago and has developed into the world's leading consumer goods company with a portfolio including some of the most trusted brands on the market. Their product portfolio includes 60+ individual brands with one of them being "Personal Health Care", where this position will be located. The client is operating in more than 100 countries worldwide and has almost 100.000 employees.
I look forward to your application!