Regulatory Affairs Senior Manager - CMC
My client, a global biopharmaceutical company, are seeking a RA CMC Senior Manager for their site in Hertfordshire. The role will sit within the Global Regulatory Affairs department and focus on a mix of development and maintenance of licences.
- Global CMC submissions for IND/CTA/NDA/MAAs and post approval maintenance
- Authoring of CMC dossiers
- Engaging with Health Authorities
- BSc degree educated or above
- CMC submissions experience in the EU and/or Emerging Markets
- Experience working within a pharmaceutical or biotech organisation
- Authoring of Module III expertise
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Czuprynski on 0203 8692 329 or upload your CV on our website www.proclinical.com. Full job description available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.