Junior RA Consultant Bio-pharma (Digital health)


Job description:

A regulatory consultancy firm supporting startups specializing in drugs, Bio-Pharma therapeutics and innovative medical devices is seeking for a new team player for the RA department.

The candidate will provide RA consulting services to meet client expectations through supporting the design and development of products from a regulatory perspective, actively contribute in the development of regulatory strategies for product development and approval as well as product lifecycle. Reporting to RA Director.

Required qualifications:

  • Enthusiastic and eager to learn regulatory affairs
  • Excellent verbal and written communication skills enabling interacting with customers with a service oriented attitude, understand customer needs and challenges and adapting accordingly
  • Self-learner and team player.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Ability to capture both the "big picture" and technical details
  • Ability to adhere to timelines, act with a sense of urgency in an environment requiring rapid and prompt responses

The candidate will need to:

  • Demonstrate a rapid learning curve and will be required to write English proficient regulatory documents.
  • Product submissions, global registrations and communication with authorities
  • Coordinate and prepare document packages for US FDA and EMA regulatory submissions, EU MDR Technical Files, and international packages.
  • Interacting with CROs both on a local and global level
  • Acting as an operational delegate of the customer for diverse activities

Occupational background:

  • M.Sc. or Ph.D. in Life Sciences/ Biotechnology & food Engineering
  • M.Sc. in Digital Health – Advantage
  • Experience with In Vivo and In Vitro studies design
  • Excellent Scientific writing – Must

Job location