Senior Regulatory Manager or Manager / Specialty Products / Generics and Branded Products

Senior Regulatory Manager or Manager, Specialty Products, Respiratory – Generics and Branded Products

The Product Portfolio is largely in Respiratory; however, specific Therapeutic area experience is not strictly necessary.

Are you already a Regulatory Manager/or experienced Regulatory Project Manager, ready to take the step-up to Senior Manager? If so, this is the opportunity you have been waiting for. This Senior Regulatory Manager, EU is for a fast-growing Pharma Company in the North of London area; this organisation has a highly successful established product portfolio and is expanding into new Therapeutic areas. The company is focused on both Branded and Generic Products.

You will be required to Project Lead and Manage and mentor Regulatory Staff. You will be responsible for the Pre- and Post-Registration and Post Marketing Team and the implementation of EU and Global Regulatory Strategy to maintain the organisation’s existing product licences, and to integrate newly approved products into the portfolio.

Management of overseas Affiliates and other Partners. Liaison with appropriate Regulatory Authorities.

Technically, you will have good working knowledge and experience of Registrations and Post marketing activity and some Pre-Registration & Development experience would be beneficial: CMC and non-CMC combination; CTD/Dossiers for MAA’s (ideally, all Modules 1 to 5, particularly 1/2/3); National Submissions/MRP, DCP and Centralised Procedure; Post marketing/Life-cycle management: Type Ia, Ib and II Variations and Renewals; Labelling, PIL’s and SmPC’s. Your geographic scope will be Pan-European and possibly some International territories.

Candidates from a Pharma or Biologics background in European Pre- and Post-Registrations and Regulatory Life-cycle management with over 5 years’ experience, and good Project Management 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.

Flexible working is considered after the period of the Lockdown.

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, julian@turnerregulatory.com 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.