Senior Manager Regulatory Affairs (f/m/d) 100%

We are looking for an Senior Manager RA (permanent position, 100%, f/m/d) with excellent communication skills and a business mindset who provides value-added input to internal stakeholders and clients.
You will take full responsibility for your assigned projects/tasks while benefiting from a strong collaboration within our small and motivated team.

Your tasks

Within our innovative RA team, you will be responsible for:

• Hands-on regulatory dossier writing and regulatory maintenance (e.g., regulatory dossiers, import licenses and site registrations) in multi-country, -customer and -product environment in accordance with applicable regulatory rules and guidelines.
• Representation of Regulatory Affairs in internal and external (e.g., customers and authorities) stakeholder discussions and negotiations during the whole product lifecycle.
• Design and ownership of regulatory strategies for development, rollout and life-cycle stage projects.
• Delivery of regulatory advice to internal and external stakeholders and of regulatory assessments within the framework of change control.
• Steering of site-overarching initiatives for improvement and innovation while proactively anticipating challenging situations.
• Management of internal and external stakeholders to reach regulatory objectives while demonstrating high degree of integrity, reliability, resilience, tenacity, openness and collaborative spirit.
• Coaching RA members, as well as actively contributing to the knowledge -building and transfer within the RA Unit.

Your profile

• University degree Master and/or PhD with focus on natural sciences (Chemistry, Pharmacy, or similar field).
• Further training and certification in the relevant discipline.
• At least 5 years of professional experience in regulatory affairs function.
• Solid experience with the preparation, including technical writing, of Chemistry, Manufacturing and Control sections.
• Solid experience with the registration requirements for Active Pharmaceutical Ingredients.
• Solid experience of the regulatory requirements, dossier submission and life cycle management for Active Pharmaceutical Ingredients for global markets.
• Solid experience in communication with customers and regulatory agencies.
• Fluent and persuasive in French (C1) and English (C1) – German as a plus.
• Experience in supervising complex projects and establishing regulatory strategies.

We offer

We offer an exciting and challenging position in a dynamic environment that guarantees you diversity. You will be joining a team of qualified specialists, and you will be able to develop yourself professionally. In addition, we offer you the opportunity to work in an innovative environment and in a motivated team. You can expect modern terms of employment and attractive fringe benefits.

Interested

Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) online via Recruiting-Tool.