For our client, an international pharmaceutical company, we are in search for a Regulatory Affairs CMC Associate Manager in the region of Basel.
What the company offers you: An international environment Modern building Company is easily reachable by car or public transport Interesting project till 20.12.2019 with chances of extension
Your responsibilities: Authoring high-quality CMC documentation for HA submission by applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle Identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Establishing and maintaining sound working relationships with partners and customers Assuming activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities
Your profile: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Regulatory experience
Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable Reasonable approach to risk assessment as well as excellent written/spoken communication and negotiation skills Fluent English (oral and written). Good skills in site (local) language desired (oral)
Welcome to nemensis!
We are looking forward to getting to know you!