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Regulatory Affairs Director / Associate Director posted by Apex Recruitment

Full Time
CM1, Chelmsford, Essex

Job Description

DETAILS:

* Full-time permanent position

* Office based in Essex

* Competitive package

THE ROLE:

* Lead EMA procedures including orphan applications, PIPs and MAAs

* Point of contact for agency interaction

* Provide expert EU regulatory strategy

* To be a client lead

* Provide leadership in scientific advice meetings at national agencies and EMA

* Project management/lead responsibilities

* Client facing with strong communication skills, willing to travel

* To assist the senior management team by providing leadership support to a team of internal consultants and their clients

* To assist the company in providing regulatory knowledge to business development colleagues during bid defence

Full job description available on application

THE CANDIDATE:

Essentials:

* Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines

* 5+ years broad & deep European regulatory affairs experience in development stage programmes

* Demonstrable experience in liaising and negotiating with regulatory authorities and point of contact with EMA

* Demonstrable experience in centralised MAAs, orphan applications and PIPs.

* Strong understanding of the regulatory environment including guidelines

* Ability to lead team members in a matrix management environment

* Ability to work under pressure and achieve timely submission and regulatory approvals

* Excellent computer skills

* Collaborative approach and able to work effectively with matrix based teams involving internal staff, client teams that include independent consultants

* Confident speaker about regulatory challenges in EU and global pharmaceutical development, and able to communicate effective solutions to clients.

Preferences:

* 7+ years of experience in regulatory affairs based activities and regulatory authority interactions

* US FDA facing experience

* Only candidates with existing right to work in the UK/EU will be considered

Reference

212038720

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