Senior Associate Regulatory Affairs
CK Group are recruiting for a Senior Associate Regulatory Affairs to join a biopharmaceutical company either remotely or at their site based in Uxbridge on a contract basis for 12 months.
Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
Location: This Senior Associate Regulatory Affairs role will home based or based at our clients site in Uxbridge, Greater London.
Senior Associate Regulatory Affairs Role:
- Assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
- Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA submission (national or VHP)/IMPD generation and updates.
- Accountable for the generation and maintenance of regional CTA application dossier in collaboration with Regional Regulatory Lead.
- Create and maintain product regulatory history documents through RIM (Regulatory Information and Management System) and appropriately archive all regulatory documents and agency communications forl application process and requirements set out as per GCP and EudraLex - Volume 10.
- Accustomed to leading National or VHP new CTA submission while providing regional preferences to meet study team goals.
Apply: For more information or to apply for this Senior Associate Regulatory Affairs position, please contact Lucy or Andy on 01438 870011 or email firstname.lastname@example.org, quoting job ref 48954.
It is essential that applicants hold entitlement to work in the UK.