Job Details

Job Summary:

My innovative and expanding medium sized Pharmaceutical client is seeking a regulatory affairs snr manager with broad experience for a regulatory affairs role covering both pre and post marketing phases for a range of therapeutic categories and dosage forms. Contact Theo Moore for full details or to apply on 0207 801 3384 or via email at Cv@advregulatory.com

Requirements:

Regulatory Affairs Snr Manager London – Full Project lifecycle role with Direct reports / London

Location: Central London

BACKGROUND

This medium sized Pharmaceutical company has an extensive late stage pipeline and is already moving up the rankings for sales in European and International markets. This is the European head office and the base of all major decision making for regulatory affairs. You will receive excellent support from the Head of R&D and specialist training will tailored to your own individual needs.

The cultural is relaxed and supportive and will suit a confident a regulatory affairs professional who is looking for a Head of regulatory role for a medium sized but still expanding Pharmaceutical company.

The salary and benefits package here are exceptional and you will receive a high level pension and healthcare package.

PRIMARY DUTIES

As the Regulatory Snr manager you will be managing a small team that is set to grow you will set out strategy, direct and contribute to planning, preparation, review and submission of high quality applications to regulatory authorities leading to approval in a timely manner.

These submission may include (but is not restricted to):
- Marketing applications, Variations, Line Extensions etc.
- Clinical trial (& Ethical Committee) applications and amendments
- End of study notifications, clinical study report & safety summaries
- Meeting briefing packages
- Scientific advice & protocol assistance requests
- Answers to regulatory questions

QUALIFICATIONS / EXPERIENCE REQUIRED

You must have a detailed knowledge of local and EU legislation on clinical development and life cycle management of pharmaceuticals and experience in interpretation of legislation pertaining to clinical development and marketing authorisation procedures/marketed products.

TO APPLY:
If you wish to apply for this role please click below, or send your CV with a covering note to cv@advregulatory.com quoting reference number noted above. Alternatively to have a confidential discussion about this or other potential roles or career options call Theo Moore or Matt Greig on 0207 801 3384

About ADV Regulatory
Advanced Regulatory has operating since 2004. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs, Quality Assurance, Clinical Development, Pharmacovigilance and Health Economics and Outcomes Research. We match professional candidates to the best permanent, contract and interim roles in the market.
Visit us at www.advregulatory.com

Key words: Regulatory, Regulatory Affairs, Reg Affairs, Regulatory Affairs Director, Regulatory Affairs Associate Director, Regulatory Affairs Senior Manager, Regulatory Affairs Manager, Regulatory Affairs Executive, Regulatory Affairs Officer.