CK Group are recruiting for a Senior Associate Regulatory Affairs to join a biopharmaceutical company remotely on a contract basis for 12 months.
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.
This Senior Associate Regulatory Affairs role will home based.
Senior Associate Regulatory Affairs Role:
- Assist in the creation and submission of regulatory documents.
- Assist & 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
- Create and maintain product regulatory history documents through and appropriately archive all regulatory documents for clinical trial applications in eTMF.
- Understanding EU clinical trial 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.
For more information or to apply for this Senior Associate Regulatory Affairs position, please contact CK Group, quoting job ref 48954.
It is essential that applicants hold entitlement to work in the UK.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: 48954
- Posted: 13th November 2020
- Expires: 11th December 2020