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Job Details

Senior Manager, Regulatory Affairs

Company: Premier Research
Location:
Reference: REG-EU
Closing Date: 24 Jan 19
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research

Requirements:

 

Role: Senior Manager, Regulatory Affairs

Location: any of our European office locations 

Contract Type: Permanent 

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. 

Working at Premier Research means being an individual - you will be recognised for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. 

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

We’re looking for a talented and energetic Senior Manager, Regulatory Affairs to join our team. This job will be recruited within Europe. The role can be home or office based and full/part time/flexible working patterns can be considered.  

You'll be accountable for:

  • Developing effective regulatory strategies, procedures and systems to facilitate efficient review and approval of regulatory submissions.
  • Management and oversight of European regulatory submission activities with the exception of clinical trial applications
  • Primary regulatory agency contact for assigned project
  • Preparation and project management of paediatric investigation plans, orphan drug applications, scientific advice briefing packages etc
  • Coordinating the preparation of regulatory submissions, and reviewing all documents submitted to regulatory agencies
  • Providing consulting services by writing and reviewing global regulatory strategy documents for medicinal products and devices
  • Communicating with regulatory agencies on behalf of clients
  • Potentially participating in business development activities

You'll need this to be considered: 

Educational Background

  • Undergraduate degree or its international equivalent in clinical, science or health related field from an accredited institution or a licensed healthcare professional.

Experience

  • Extensive experience working in Regulatory within Clinical Research 
  • Strong experience in European regulatory submission activities
  • Thorough knowledge of ICH and local regulatory authority drug research and development regulations preferred.
  • Experience working with internal and external customers/vendors to meet project specific goals.

Expertise and know-how

  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Knowledge of web based communication tools for conferences

Personal skills & behaviours

  • Fluent verbal and written English.
  • Excellent team player, collaborative and able to build an effective team.
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Strong verbal and written communication and mediation skills.
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines.
  • Accountable, dependable and strong commitment.
  • Is customer service focused in approach to work both internally and externally.
  • Maintains a positive, results orientated work environment.

KEY WORDS: Regulatory Affairs, Regulatory, Paediatric Investigation Plans, Orphan Drug Applications, Pharmaceuticals, CRO, Contract Research Organization, Permanent, Europe, Ireland, Germany, Italy, France, Spain, Bulgaria, Slovakia, Biotechnology, Office Based, Home Based

Apply for this job: Senior Manager, Regulatory Affairs

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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