(Senior) Specialist Regulatory Affairs NCE (f/m/d) 100%

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

We are looking for a well-organized and highly motivated experienced RA professional who provides value-added input to internal stakeholders and clients. You are working within our small and innovative RA team.

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:

Compiling regulatory documents (e.g. clinical trial regulatory dossiers, client data packages, DMFs) in line with regulatory requirements and customer’s requests, according to the defined timelines
Developing dossier content strategies
Answering deficiency letters from Authorities
Performing regulatory assessment of changes as part of GMP change control
Preparing regulatory documents to support post-marketing changes (e.g. "Variations") and submitting them accordingly, where applicable
Providing regulatory advice to and answering regulatory questions from internal and external customers, throughout the product lifecycle (including development)
Defining, communicating and keeping RA-related timelines for his/her projects
Representing RA in project teams for NCEs

Your profile

Master or PhD in chemistry or pharmacy or an equivalent qualification
Fluent in English and - as a plus - German (basic knowledge is required)
Flair for presenting scientific facts
Excellent written communication skills
Committed, creative, 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

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. If this interesting position appeals to you, then we look forward to receiving your application.

Interested? Please submit your complete application through our recruitment system.

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