Senior Associate Regulatory CMC Biologics / Top Biopharma / EU & International

Senior Associate Regulatory CMC – Biologics, top Biopharma

Excellent opportunity for a Senior Associate Regulatory CMC, or an experienced Regulatory CMC Associate, with a solid background in Regulatory CMC and ideally Biologics (not essential)

Working knowledge of Biologic products is ideal although Pharma Product experience can be considered.

This leading Biopharma Company seeks a Senior Regulatory Officer for their team based in Central London with Hybrid Working offered; ideally, you will be seasoned in the following processes: CTA’s, IMPD’s (CMC sections); CTD/Dossiers for MAA’s (Modules 2.3 and 3); European Procedures: mainly Centralised Procedure; Post marketing: Type Ia, Ib and II Variations and Renewals.

It is generally accepted that this company is a superb organisation to learn and develop new Regulatory CMC skills.

Liaise closely with Regulatory CMC Managers, Business Development, other Regulatory Affairs, Pharmacovigilance, Product Launch, Supply Chain and Quality colleagues to ensure alignment in all initiatives.

Contribute to Regulatory Strategies (including advising of the Regulatory requirements) for new Marketing Authorisation Applications / Post-approval Submissions.

Be actively involved in due diligence activities including evaluation of Regulatory Strategy and launch timelines, evaluation of risk.

Candidates from a Biopharma or Pharma background in European Regulatory CMC and Life-cycle management with over 3+ years’ experience, and good all-round Regulatory CMC skills should be suitable for this position.

You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.

£55,000 basic, 12% bonus, LTIs’/RSU’s and other leading benefits are offered. Central London location with Hybrid Working.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner at Turner Regulatory Recruitment on 0203 695 9477/07447 977 330 or by clicking Apply Now.

 

 

Some Of Our Feedback

  • A fast-growing Biotech Company were struggling to find a Vice President, Global Regulatory Affairs and having engaged a major Executive Search firm in the USA had spent over 1 year looking for the right candidate without success. Within 8 weeks of requesting my help, we provided the company with 12 candidates, from which the ideal candidate was selected, who, over two years on, is still successfully operating within this role.

  • A leading Biopharma Company were looking for an Associate Director, Regulatory Strategy Team Lead for Emerging Markets, but had thus far failed to secure the right candidate. In fact, after 6 months of trying they’d only been able to secure an interview with one, less than ideal, candidate. Within 30 days of working with myself, a very suitable candidate was identified and started working for the company within 3 months. We provided the Biopharma Company with 11 excellent candidates to choose from.

  • A Pharmaceutical Company contacted me to find their new Head of Regulatory Affairs, to be based in a challenging location. Within 60 days of approaching me, after an intercontinental recruitment campaign, 6 candidates were identified and delivered. A suitable candidate was chosen and placed. The Company expressed their gratitude for having exceeded their expectations.

  • A newly created Vaccines organisation tasked Turner Regulatory Recruitment with finding a Head of Region, Senior Director, EU Regulatory Affairs. At the time, there were a number of Biotech/Vaccines companies seeking to fill similar positions; however, in spite of these challenging market conditions 13 candidates were identified and put forward from the ensuing short-listing process, one particular candidate was chosen, offered and accepted; this candidate is still happily in situ.

  • A well-established and commercially successful Biotech Company was having trouble in sourcing a Senior Director Regulatory CMC with a European/EMEA focus for their London Office. This organisation had been seeking to fill this role using numerous Agencies/Head-hunters for well over 6 months without success. Turner Regulatory Recruitment took a fresh and targeted approach to the role, identifying and delivering 8 excellent candidates. From the following interviewing process, not 1, but 2 candidates were offered, and both accepted.