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Regulatory Affairs - Regulatory Affairs Manager Jobs - Berkshire

Regulatory Affairs - Regulatory Affairs Manager Jobs - Berkshire (Job Ref: WR/JOBS/18994-7033)

Job Description :

 Job Summary

Flame Pharma Regulatory Affairs - Regulatory Affairs Manager Job - Berkshire:

An opportunity to work with a leading Regulatory Affairs Consultancy has arisen for a talented and skilled Regulatory Affairs Manager. If you are looking for a challenge and to accelerate your career by working on multiple projects for world leading clients, then this position is for you.

Job Title

Regulatory Affairs Manager

Background

Due to expansion, our client is looking to recruit a Regulatory Affairs Manager to be responsible for people and project management on company projects.

Please note: This role can offer flexible working hours and can be full or part time.

Key Responsibilities

• Preparation of high quality, detailed regulatory documents using varied information sources
• Plans and conducts activities of considerable complexity within the regulatory field
• Has supervisory responsibilities for several projects/products
• Can access relevant regulatory information from internal or external sources
• Undertakes and advises on specific regulatory projects with minimal input required from clients
• Set out the lines and strategy for a project
• Actively solves project / function-related problems within the area of the project
• Interacts with regulatory authorities on specific project / product issues as required
• Collecting data on regulatory intelligence and can be used as a source for regulatory information for members within the team
• Coordinates the work of multiple projects/products in a way that agreed deadlines are met and status records are maintained
• Keeping up to date with (international) legislation, guidelines and customer practices by attending courses, seminars and reading guidelines, directives and articles
• Maintaining quality systems
• Uses information from regulations, guidelines, publications and or other sources where required
• Undertakes activities in a wider range in the regulatory environment
• Liaises with relevant personnel within the working environment to obtain an understanding of client requirements
• Assisting in client development activities which may involve to travel to client sites nationally and internationally
• Leading and managing a team of permanent regulatory consultants, providing training, coaching and expertise as required
• Supervision and development of regulatory consultants – junior to senior executive level
• Adheres to Company’s (and Clients where appropriate) processes and procedures and presents a professional manner as a Company representative

Qualifications and Experience

• Ideally BSc or MSc degree in a scientific field 
• Extensive proven experience in the regulatory affairs field
• Proven project and man management skills
• Willingness to travel to client sites on a regular basis
• Demonstrable ability to coach, train and mentor teams
• Ability to write articles for journals
• Proven client relationship management skills
• Excellent communication skills
• Proven application of extensive skills in the Regulatory Affairs environment
• Applies extensive knowledge and experience to impact project / function direction
• Possesses organisational awareness and effectively utilises this knowledge
• Ability to work to strict deadlines under pressure

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary in the region of £50,000-£60,000.

Key Words

Regulatory Affairs, Regulatory Affairs Manager, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

The position will be based in Berkshire