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Job Details

Head of Regulatory Affairs

Company: Planet Pharma Staffing Limited
Location: Belgium
Reference: SCRA0301
Closing Date: 03 Feb 18
Type: Full Time
Salary (£): 100,000+
Benefits: Attractive

Job Summary:

My client is a biotech with a strong pipeline in the field of Neurology and an extremely knowledgeable and senior team of Regulatory experts. A high profile role within the business has become available as Head of Regulatory Affairs which requires no less than a vastly experienced and knowledgeable RA expert with strong leadership qualities.

Requirements:

Extensive experience in:

  • Regulatory Affairs and Quality Assurance,
  • Biologicals medicinal products,
  • Small molecules medicinal products,
  • Global pharmaceutical development,
  • Marketing authorisation Applications (MAA) (Centralised Procedure,
  • Mutual Recognition Procedures, National Procedures),
  • Biologicals License Applications (BLA),
  • Scientific Advices,
  • Paediatric Development,
  • Orphan designations,
  • pre-IND meetings,
  • pre-BLA/NDA meetings
  • Health Authority dialogue and negotiations,
  • Launch of several new products,
  • People management, inspirations and processes,
  • Membership: executive development committees and development steering committees
  • Regulatory expertise in development within ophthalmology

Key experience:

  • Ability to demonstrate exceptional leadership qualities as well as the ability to manage a small team in a small environment
  • Extensive Regulatory development experience working with biologics
  • Experience with EMEA and FDA

DURATION

Permanent

 

COMPENSATION

Attractive salary plus benefits package

 

LOCATION

Office based in Belgium (commutable from Brussels/Leuven)

 

ABOUT PLANET PHARMA

  • Planet Pharma was founded by a dedicated team of seasoned professionals with extensive experience supporting the pharmaceutical, biotechnology and device industries. We are a unique staffing agency that have dedicated recruiters solely focussing on candidates to support the clients we work with.
  • Innovative – We constantly explore new ways of working that will help us be more efficient and effective
  • Entrepreneurial – We look at things differently, immerse ourselves in your world and devise solutions for each and every client
  • Expert – Everyone on our team is an expert in their field, trained and continually learning to deliver an unrivalled level of experience
  • Passionate – We are all incredibly proud to be part of Planet Pharma and we genuinely care about the people we work with
  • We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

 

APPLICATIONS

Please contact Sam Chapple at Planet Pharma on +44(0)203 868 8607 / schapple@planet-pharma.co.uk

 

Apply for this job: Head of Regulatory Affairs

Contact Information:

Address:  Head Office
10 Greycoat Place, London,
SW1P 1SB
England
Tel:  +44 203 868 1000
Website:  Visit Our Web Site

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