RA CMC Associate Manager
Posted on Jan 23, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Basel we are looking for RA CMC Associate Manager for 9 months project
Job Title: RA CMC Associate Manager
Duration: 01.04.2020 - 20.12.2020
Under supervision and guidance, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
. Author high-quality global CMC documentation for Health Authority submission throughout the product life cycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. 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 documents in accordance with project timelines.
. As needed, 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.
. Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
. Minimum: Science Degree (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
. Desirable: Advanced Science Degree
. Fluent English required (oral and written). Excellent written/spoken communication skills.
. Experience in regulatory and/or 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.
. Ability to work successfully with global project teams and prioritize activities considering timelines and workload.
. Effective planning, organizational and interpersonal skills
. Computer/IT systems literacy