Associate Director Regulatory Affairs EU – Central London, UK

Reference: MGJM10577A

Expiry Date: 09-02-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
London
Greater London
United Kingdom

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Job Description

About the Client

Our client is a R&D small-sized pharma with a site in Central London with a specialty development pipeline focused on internal medicine and neurology, it’s a friendly team with a stable working environment, low on politics, with open and inclusive senior management. They are growing their portfolio and hence are looking for an all-rounder who likes doing a full lifecycle role: clinical regulatory, lifecycle, some strategy, and agency liaison, with an EU focus at the Associate Director Regulatory Affairs level.

About the Role

The role will be overseeing the regulatory activities for all designated projects/products supporting and providing regulatory and submission strategy working with the regulatory teams in EU with some liaison to the US team. Some of your duties will include to lead the preparation of CTAs, MAAs and Line Extensions, PiPs, and preparation / attendance with the UK and EU Health Authorities.

You will with the Senior Director, support / lead regulatory and submission strategy discussions, often coordinating the plans with CROs. To be successful at this role you will be a friendly communicator, happy to work in a team and standalone, with functional groups in the UK and US for clinical, registration and post-marketing submissions.

About your Experience

Individuals with a minimum of 6 years or more experience in the pharma/biotechnology industry within regulatory affairs, with knowledge of pre-/post-marketing regulatory, knowledge on European Regulatory procedures (CeP, DeCP) and strategic regulatory mind-set, with the abilities to create a positive impact and represent the company in front of the regulators.

Package & Relocation

A strong  package is available to include a high basic, good bonus and yearly vesting stock plus a comprehensive benefits package for you and your family.  Relocation assistance available if needed.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore on +44(0) 207 801 3384, or my colleague Matt Greig on +44(0) 207 801 3386. We will support you throughout the interview and on-boarding experience.

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