Head of Regulatory Affairs - Liverpool, United Kingdom - Proclinical

Proclinical

Verified Company

Liverpool, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Proclinical are partnering with a CRO who are recruiting for an individual to join their team.

This role is on a permanent basis and the opening position that is available is for a Head of Regulatory Affairs.

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Responsibilities:

Provides strategic regulatory input to all assigned projects.
Management, preparation, assembly of the Master Core Dossier and submissions of European:
Clinical Trial Authorisation Applications (CTAA) and amendments
Countrylevel Informed Consent and other patient facing documentation.
Tracks, reports and files CTAA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
Proactively provides strategic direction to the client on regulatory specific issues and provides associated mitigation as required.
Participates in the quality control (QC) steps involved for all the above.
Serves as key regulatory liaison for multicontinental project. Liaison with other departments, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
Maintains metrics on a monthly basis of all regulatory submissions.
Strategic crossfunctional interaction with a variety of departments to provide EU regulatory solutions to problems including the management of timelines to complete regulatory submissions on time
Responsible for providing assistance to perform effectively the

- planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approval.

Validate and provide input into our clients' regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required.
Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA's.
Supports Regulatory Director in business development activities including the preparation of client proposals and bid defense meetings.
Provides regulatory training to other members of the team as required.

Key Skills and Requirements:

Bachelor's degree required preferably in a life science field or equivalent
Be informed and aware of European and US Regulatory developments.
Knowledge of oncology study endpoints
Detailed knowledge of ICH-GCP/FDA requirements
Excellent interpersonal skills
Proven ability to demonstrate problem solving skills.
Proven ability to meet deadlines.
Strong communication skills: verbal/written.
Highly organized and resultoriented
Good knowledge of Windowsbased software programs

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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