Meera Pattni at CK Regulatory is currently recruiting for a Head of R&D Regulatory Affairs to join a successful pharmaceutical company based in West Sussex.
The role:
As Head of R&D Regulatory Affairs you will be responsible for ensuring proper procedures and processes are in place to meet compliance needs. You will also ensure Pharmacovigilance activities are in line with SOPs.
Further responsibilities of this Regulatory Affairs position will include:
- Develop UK Regulatory/Medical Affairs plans and take corrective actions when needed to ensur etimelines and objectives are achieved.
- Develop/build on strong and sustainable relationships with Health Authorities to overcome barriers and expedite product registration processes.
- Ensure customer excellence by delivering quality support for the Company’s project review boards and regional Innovation and BD&L process and collaborate to deliver planned sales aligned with annual business plans.
- Monitor country government actions, legislation and OTC industrial organisation actions.
- Ensure operational excellence through effective implementation of global regulatory information management and global labelling compliance initiative.
- Ensure compliance review of the portfolio in collaboration with Region/Global QA.
- Build drug regulatory affairs/medical affairs organisation in line with strategic plan.
- Knowledge of global pharmacopeias, local and global regulations, compendiums, innovative new techniques.
- MA submissions, approvals in line with Global / Region objectives.
- RA Compliance review in line with annual plans.
The ideal candidate:
Meera is looking for candidates with the following qualifications, experience and skills:
- Life sciences degree, educated to Masters level preferable.
- Strong background in regulatory affairs.
- Line management experience essential.
- Pharmacist background preferable.
- Understanding of local market business needs and environment.
- Strong communication and negotiation skills.
- Strong interpersonal skills.
How to apply:
For more information or to apply for this Head of R&D Regulatory Affairs position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23209 in all correspondence.


