Overview
We are looking for a 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
* 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, you will have 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.
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