To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Regulatory Affairs Team we are looking for a dedicated (Senior) Regulatory Affairs Specialist Generics (f/m/d), 100%.
Your tasks:
Within our creative Regulatory Affairs team, you will be responsible for:
* Preparing and submitting pre- and post-marketing regulatory documentation including correspondence with health authorities and customers
* Developing registration pre- and post-approval strategies
* Answering deficiency letters from health authorities
* Performing RA assessment of changes as part of GMP change control
* Providing regulatory advice to and answering RA-related questions from internal and external customers, throughout the product lifecycle (including development)
* RA representation in project teams
* Defining, communicating and keeping RA-related timelines for your projects
Your profile:
* Master or PhD in chemistry or pharmacy or an equivalent qualification
* Fluent in English; Proficiency in German is a significant advantage
* Flair for presenting scientific facts
* Committed, innovative, solution-oriented, well-structured work-attitude honoring timelines
* Strategic mindset
* Convincing attitude and persuasive communication
* Understanding for concepts and principles
* Experience in Drug Regulatory Affairs with generic drug products or corresponding drug substances is a significant advantage
Our offer:
* A dynamic and rapidly growing work environment with internal development opportunities
* Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
* Employee development through numerous internal and external training opportunities
* 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
* Access to the Swibeco benefits platform with discounts from external partners
* Fresh, healthy and varied food in our staff restaurant
* A wide range of free sports activities on the Bachem Campus
Would you like to drive innovation together with us?
We look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and get inspired by our exciting work environment at our location in Bubendorf!
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