Reference Number: JO-1912-443316
Regulatory Affairs Associate Director
Job Type: Permanent
Regulatory Associate Director/Director
Attractive salary and benefit package
Regulatory Professionals are currently working with an established privately-owned consultancy based in Hampshire. Due to continued growth, they are looking for an Associate Director/Director of Regulatory Affairs to join the team on a permanent basis.
The business is known for their ability to deliver unique, complex and innovative projects and the capabilities to provide a complete drug development service to pharmaceutical and biotech clients across the globe. This exciting organisation support activities that span from early pre-clinical through to post marketing.
This is a unique opportunity to be part of a successful senior team with a great company culture and business values.
Job Responsibilities include;
Act as the lead on global regulatory projects; coordinating, preparing, reviewing and submitting regulatory submission
Developing global regulatory strategy
Agency meetings (Scientific Advice, Protocol Assistance, pre-IND and FDA meetings)
Orphan Drug Designations in the US and EU
EU/Rest of World Marketing Authorisation Applications
Client management including provision of high-quality deliverables on time, on budget, while fulfilling client needs and maintaining engaged project teams
Business development, including writing proposals, creating project budgets and attending bid defence meetings
Candidate Requirements include;
A life science degree (or equivalent)
A can-do attitude! Ability to work under own initiative, comfortable to run and lead projects and to be client-facing
Strong software and computer skills, including MS office applications
Eligibility to work full-time in the UK
This is a senior hands-on role that will suit, self-motived Regulatory professional who enjoys working in a client facing role on a broad spectrum of projects including challenging programmes and rare diseases. If you are interested in discussing further please call Sophie on 01189 522 797 or email firstname.lastname@example.org.