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Regulatory Affairs Associate – Medical Writer

We are seeking a Regulatory Affairs Associate with experience in new drug approval process and knowledge in clinical trial procedure.

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Time Status: Full-time / Remote
Location: Hamden, CT Location in New England is preferred
Salary: Competitive

Job Description

Vanessa Research is a Connecticut based biomedical company that discovers, develops and commercializes innovative medical products in areas of unmet medical needs.

We are seeking a Regulatory Affairs Associate with experience in new drug approval process and knowledge in clinical trial procedure. The candidate will prepare, coordinate, review and submit domestic and international regulatory applications for clinical trials, collect all the necessary documents, approvals; effectively plan and manage regulatory variations. The ideal candidate must be familiar with European and US regulatory systems. The Regulatory Affairs Associate will work closely with the Research & Development and Manufacturing division.

The position will provide an opportunity to contribute to the strategic directions of the company and make impact by supporting our ultimate goal of ‘giving hope where none existed.’

Duties and Responsibilities:

  • Prepare, coordinate, review and submit domestic and international regulatory applications
  • Maintain relationships with local and foreign authorities and act as a regulatory contact

Writing and submission of:

  • applications for early phase (I-II) clinical trials
  • special status applications (such as ODD applications)
  • pediatric investigation plans

Qualifications

  • Degree in Medicine, Life Sciences, Pharma and/or Law
  • 3-5 years of experience in relevant position
  • Proven record of successful regulatory applications
  • Proficiency with European and US regulatory systems
  • Excellent time and project management skills
  • Effective communication skills
  • Excellent writing skills
  • Ability to work effectively in a diverse work environment
  • Proficient with MS Office tools

What we offer

  • Competitive compensation with bonus performance incentives
  • Working with a global, diverse team of dedicated, highly-skilled professionals
  • Opportunity to join a rapidly growing business at an early stage, where each employee can make a difference and directly contribute to the success of the company

About Vanessa Research:

VRI was founded on the desire to build a 21st century, sustainable, innovative, entrepreneurial organization by bringing together a collection of diverse scientists, engineers, business professionals, and academics to create solutions in medicine. The company has etched its niche in developing innovative products by commercializing complex ideas with simple solutions. This is done by creating a “fun” respectful teamwork environment conducive to open unrestrained dialog and invention.

If interested, please send your English CV and cover letter to hr@vanessaresearch.com

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