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Senior Specialist Regulatory Affairs NCE (f/m/d) 100%
Basel area, Switzerland
Our client is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides. As a full service provider heoffers products for clinical development and commercial applications as well as a comprehensivthe partner of choice for the biotech and pharma industry worldwide.
We look for an experienced RA professional with excellent communication skills and a business mindset who is adept in strategic solution-finding.
You will take full responsibility for your assigned projects/tasks while benefiting from a strong collaboration within our small and motivated team. e catalog and exclusive custom synthesis.
- Support NCE business by promoting RA Services in client interactions
- Establish regulatory collaboration with clients
- Negotiate regulatory support options with internal and external stakeholders
- Provide RA Advice to NCE CMC development projects teams
- Develop, present and defend regulatory strategies
- Represent RA in project teams for developmental NCEs
- Simultaneously handle various projects with different support needs
- Coordinate project-related RA-activities and keep the RA team up-to-date on the projects
- Share learnings and experiences within the team
- Master or PhD in chemistry or pharmacy or an equivalent qualification
- Solid understanding of and practical experience in Drug Regulatory Affairs
- Excellent communicator, fluent and persuasive in English and – as a plus – German
- Strategic, creative, solution-oriented, pro-active mindset
- Flair for business aspects
- Quick thinker with understanding for concepts and principles
- Self-motivated, committed, well-structured work-attitude
- Ideally, experience in CMC development and in project work within the pharmaceutical industry
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.
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