Job title: Regulatory Affairs Associate Director UK/IE

A Global Pharmaceutical company in Essex are recruiting for a Regulatory Affairs Associate Director UK/IE. This role will have responsibility for Regulatory affairs ownership for all new UK and IE Marketing Authorisation submissions for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.

Responsibilities:

Full lifecycle management of product allocation including support of all new product launch activities for both UK and IE.
Fulfillment of line management related responsibilities for 6 direct reports
Ensure R&D receive the regulatory guidance necessary to ensure that responses are submitted on time and that content is aligned with MHRA/HPRA data requirements.
Provide regulatory support throughout product development to approval for local co-development initiatives and local in-license of new products
Formulate regulatory strategies for all products within the team for new submissions and post approval changes.

Requirements:

Experience in regulatory affairs in pharmaceuticals and previous experience of managing teams.
Demonstrated experience of contact and relationship with MHRA and HPRA.
Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms including generics, new chemical entities, devices and OTC products.
A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations.

Salary and benefits:

A highly competitive salary, annual bonus, car allowance, private medical and a wider benefits package is on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk