Job Details  
Advertiser: Haybury

Job Title: Associate Director- Regulatory Affairs – 6
Rate:£ Per Year    Benefits: Excellent
Description: A great opportunity has arisen to work within a prestigious pharmaceutical company based in the UK dealing with a range of strategic regulatory activities in a European setting. The role will be based in their research and development site giving you great exposure to the scientific driving activities of the company.

With an impressive product portfolio and strong pipeline they are looking for an experienced regulatory strategist to lead a number of new submissions in Europe

Within this role you will:

• Lead and coordinate all regulatory strategy for development and late stage projects for assigned therapeutic area specifically in Oncology and Orphan Disease
• Participate in the development of new drugs, define regulatory strategy and lead regulatory interactions with Health Authorities on a Europeans basis
• Prepare technical documents appropriate for regulatory submissions (MAA, IND and NDA such as briefing packages for scientific advice or pre-submission meetings, paediatric investigational plans and clinical trial applications.)
• Lead and support various cross matrix projects, such as business development assessment, due diligence and licencing
• Prepare and review Paediatric Investigational Plans (PIP)

You will bring to the role:

• Degree in life science, pharmaceutics, natural science or medicine (such as MSc, PhD, MD)
• Relevant experience within Biotechnology or Pharmaceutical industry
• Proven experience within a regulatory affairs setting for both development and established products
• Registration experience within Europe as a minimum,
• Therapeutically exposure in Oncology

In return you will receive:

• Competitive rates
• The opportunity to work in a global and state of the art environment

If you have the skills and experience for this opportunity and the ambition to take on this position, please call Shen for further details or email your CV today.

Contact Shen at +44 1273 727 930 or

Shen is a Senior Client Partner at Haybury Search covering Europe, UK, North America and Asia.

Key Words: Regulatory, director, Regulatory Affairs, development, strategy, European, FDA, MAA, EMA, Strategy, Cross Functional, LCM, lifecycle manager, submission, applications, dermatology, skin, psoriasis, therapeutic, EU, IND, NDA, Oncology, Orphan, PIP
Skills Required: Regulatory, director, Regulatory Affairs, development, strategy, European, FDA, MAA, EMA, Strategy,
Job Type: Contract
Start Date: ASAP     Duration:
Contact: Shen Mawani Contact E-mail: Click
Contact Tel: 01273 727 930 Contact Fax: 01273 327 685
Reference: SM5720 Added: 15-08-2017
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
Home   •   About us   •   Privacy Policy   •   Terms   •   Contact Us   •   Help
Copyright © 2013