CK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company at their site based in Cambridge on a contract basis for 12 months.
up to £45.56 ph (PAYE) or up to £60.35 ph (Umbrella / LTD)
Regulatory Affairs Manager Role:
? Manages in the development of the regional product label by collaborating with the Labeling Working Group.
? Supports regional label negotiation activities.
? Act as a contact with relevant regulatory agencies in fulfilling local obligations by product assignment.
? Under general supervision, implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
? Provides regulatory guidance on regional regulatory mechanisms to optimize product development.
Your Background: (Must have minimum of CTA and EU experience as training can be given)
? Knowledge of regulatory principles, working with policies, procedures and SOPs .
? Knowledge of relevant legislation and regulations relating to medicinal products.
? Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
? Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and International borders.
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 Regulatory Affairs Manager role will be based at our clients site in Cambridge.
Entitlement to work in the UK is essential. Please quote reference 51393.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Heather Deagle
- Phone: 0191 384 8905
- Reference: 51393
Website: CK Group
- Updated: 9th September 2021
- Expires: 7th October 2021