Respivant is a clinical stage company developing products for the treatment of rare diseases using a combination drug/device product.  We are seeking a Manager or Director of Regulatory Affairs (depending on experience and qualifications) who has a minimum of 5-10 years responsibility supporting global drug development activities.

 

Position requirements:

  • Provide hands-on leadership for the Regulatory function at Respivant
  • Draft, finalize and submit regulatory documents to worldwide regulatory authorities
  • Coordinate with functional groups to ensure comprehensive input on regulatory matters
  • Ensure compliance of the Regulatory System with the requirements of our parent company, Roivant

 

Candidate background and experience:

  • 5-10 years of experience supporting worldwide Regulatory Affairs, focused on investigational pharmaceutical products
  • Track record of successful interactions with FDA and European regulatory authorities
  • Experience successfully executing regulatory activities in the US and EU requirement
  • Familiarity with the current thinking of the regulatory authorities in US and EU relating to pharmaceutical drug development
  • Experience with regulations relating to the development of a drug/device combination product would be highly desirable

 

Education and skills

  • BS/MS/PhD in a Science filed
  • Highly productive in a team environment working with an open mind and incorporating others’ input in planning and implementation
  • Flexible in approach to identify solutions that meet all regulatory requirements yet are least burdensome
  • Excellent communication – both oral and written
  • Functionally efficient in the high-paced environment typical of early stage companies.
  • Willing to span the range of engagement from strategic thinking to hands-on drafting and submission of regulatory documents

Please submit your resume to: careers@respivant.com