My client, a biological company based in Hertfordshire is looking for a Senior Regulatory Affairs Officer.
This is a great opportunity to be part of a fast-growing and innovative company.
You’ll be joining an experienced team to ensure standardisation for their life saving products and will be exposed the global market.
CMC Regulatory Manager.
- Obtain new and maintain existing Marketing Authorisations.
- To propose and participate in Regulatory strategy decision making for new Marketing Authorisations in the US, EU or intercontinental markets.
- Participate actively with meetings with FDA and EMA.
- Actively maintain RA data bases (RIM/ IDMP), documentation and procedures to ensure regulatory compliance of products released to market.
To be considered you need to have:
- Minimum 5 years in regulatory affairs in the pharmaceutical industry with world-wide licencing activities.
- Experience in obtaining and maintaining manufacturing and clinical trial authorisations in the US, EU and Intercontinental region (ideally with knowledge of Chinese regulations and experience with drug licensing in China.)
- Good knowledge of ICH and solid knowledge of all aspects of an ICH CTD structured dossier.
- First degree in Life Sciences and/or MSc Reg Affairs degree from TOPRA.
Looking but this isn’t the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV and the best time for a call to to set up a confidential discussion about potential opportunities.
Catalyst Life Sciences
CLS are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas.
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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