4 months ago
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.
- 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.
- 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 firstname.lastname@example.org