Regulatory Affairs CMC Associate Manager (m/f) 100 %
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 31.12.2019 with chances of extension
- 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
- 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!