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Job Details

Associate Director, Regulatory Affairs - Immunology

Company: Planet Pharma Staffing Limited
Location:
Reference: DV-47683
Closing Date: 12 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

A global market leading Bio-pharmaceutical company with their EU headquarters located in the UK, is currently seeking an Associate Director, Regulatory Affairs to join the team on a permanent basis. The successful candidate will have the opportunity to work within a vibrant, passionate and hardworking team. Where they will be providing scientific insight to the Regulatory team while working on the Clinical Development of projects within EMEA.

Requirements:

Our client is a large international biopharmaceutical company with a patient centric approach. They currently have a very strong pipeline in the market with a combination of new clinical development and extensions for their licensed products. They are committed to continue expanding their portfolio by investing in research in meaningful products for therapeutic areas where there are treatment gaps, such as rare diseases, Immunology and hematology/oncology. Our client also offers one of the most competitive salaries and extensive benefits package in the market as they truly value their employees. They're currently looking for someone with a strong scientific understanding within Immunology to join the team on a permanent basis.

 

The successful candidate should have the following; 

  • Experince working within a global level
  • Good regulatory experince within Clinical Development working within EMEA
  • Strong science background, specifically within Immunology
  • FDA knowledge and experience will be considered a benefit but not essential for this role
  • Scientific degree as a minimum
  • Previous experince working within a pharmaceutical setting

 

Responsibilities: 

  • Provides regulatory expertise for New Product Planning and Licensing due diligence activities
  • Oversees submissions and compiles complex, strategic submissions for assigned projects. Ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews regulatory submissions for accuracy, consistency and quality.
  • Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements. Independently manages complex technical documents for preparation, review and submission to regulatory agencies. Independently determines the best way to position information in assigned regulatory submissions to maximize reviewability. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision.

 

Keywords:

Immunology, Regulatory Affairs, Scientific, R&D, Clinical Development, 

 

About Planet Pharma

Planet Pharma is an American parented, global Employment Business / Agency providing Global Staffing services. We are head-quartered from Chicago with our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. 

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

 

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Diana on +44 (0)20 337 879 64 or e-mail on dvalencia@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

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

 

Apply for this job: Associate Director, Regulatory Affairs - Immunology

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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