Hands-on regulatory dossier writing and regulatory maintenance in multi-country, -customer and -product environment in accordance with applicable regulatory rules and guidelines.
Representation of Regulatory Affairs in internal and external 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.

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.

exciting and challenging position in a dynamic environment that guarantees you diversity.
opportunity to work in an innovative environment and in a motivated team.
modern terms of employment and attractive fringe benefits.

Senior Manager, Regulatory Affairs

Key skills