CHE - RA CMC Associate Manager (m/w/d) 100%

For our client, a renowned pharmaceutical company based in Basel, we are seeking a:

CHE - RA CMC Associate Manager (w/m/d) 100%

Tasks & Responsibilities:

• Author high-quality global CMC documentation for regulatory submissions throughout the product lifecycle for Biologics projects/products.
• Apply agreed CMC global regulatory strategies, current regulatory trends and guide-lines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source docu-ments in accordance with project timelines.
• Coordinate, collect, store source documentation needed for direct submission to Health Authorities.
• Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.

Must haves:

• Good oral and written communication skills with a collaborative and patient-focused mindset
• Ability to work successfully with global project teams and prioritize activities considering timelines and workload
• Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
• Computer/IT systems literacy
• Degree in Science (e.g. Biochemistry, Biology, Biotechnology, Chemistry, Pharmacy) or equivalent. Advanced Degree in Science desirable
• Experience in regulatory and/or in the pharmaceutical industry preferred
• Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable
• Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Ability to critically evaluate data from a broad range of scientific disciplines. Knowledge of the drug development process desirable

General information:

• Start date: asap
• Duration: 18 months with 6 month extension possible
• Location: Basel
• Workload: 100%