Senior Associate Regulatory Affairs - Clinical Trials

Job Title: Senior Associate Regulatory Affairs - Clinical Trials

Location: Buckinghamshire

Duration: ASAP - 12 month contract

The Client: A global pharmaceutical company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Clinical Trial Regulatory Group 65%

With supervision, manages clinical trial applications (CTAs) directly to applicable Health Authorities within EAME and supports CTAs in conjunction with CROs in other relevant countries : - Plans, prepares, co-ordinates & submits CTAs including:
Communication with Regulatory Responsible Person (Dev/PLM), Global Regulatory Affairs (GRA), local country RA (where applicable), Study Team members, Publishing and CROs to gather input and collect appropriate documentation/information as applicable
Initiate response preparation to Health Authorities questions in conjunction with Regulatory Responsible person and study team, where applicable.
Maintain the CTA during its life cycle (e.g. amendments, end of trial notifications, DSURsattention to detail and timelines
Demonstrated planning and organisation skills. Ability to prioritize tasks, to work independently on multiple tasks in parallel and under time pressure
Flexible and adaptable to changing project priorities and work assignments
Excellent communication skills, both written and verbal
Fluency in written and spoken English, knowledge of other languages an advantage
Good computer skills to include: MS Word, Excel and PowerPoint
Ability to work effectively and collaboratively across the client's organisation.
Good interpersonal and negotiation skills and the ability to influence others without formal authority

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

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