Regulatory Affairs Associate

10 Jul, 2022

Jobs

Regulatory Affairs Associate

Medicago
Remote

Medicago: A history of innovation and perseverance

We started our journey with one objective: to help protect human life and today, we are a global leader in developing and producing plant-based vaccines and therapeutics.

Your role: 

Medicago is seeking a Regulatory Affairs Associate – Regulatory Operations responsible for compilation, publishing, filing, and maintenance of all global regulatory submission types (including dossiers in Canada, U.S.A., and Europe) for both pre-marketing and post-marketing activities in a timely, compliant, and accurate manner.

What your days would look like:

  • Prepare and compile eCTD and non-eCTD regulatory submissions (NDS, SNDS, BLA, MAA, IND, CTA), as directed
  • Provide report- and submission-level publishing support for regulatory submissions in PDF and Word format to ensure regulatory compliance (e.g., bookmarking, linking, PDF version, etc.)
  • Validate, dispatch, and archive submissions according to internal processes and regulatory guidelines for electronic submissions independently
  • Perform quality control checks for documents and submission publishing, understanding and addressing validation criteria, and troubleshooting
  • Fix documents to comply with writing format conventions and (e)CTD requirements
  • Coordinate with SMEs and RA Submission Managers and Leads
  • Maintain open, timely, and effective communications with all submission contributors/stakeholders
  • Plan and track regulatory submissions
  • Participate in special projects, initiatives, and process improvements (SOPs and working instructions), and associated training material
  • Maintain knowledge of regulatory requirements for document naming, submission, and publishing across various submission regions on a continuous basis

Required profile: 

  • B.Sc. in relevant field (biological or chemical sciences, or information technology/computer sciences)
  • 3-6 years experience in pharmaceutical or biotech regulatory affairs operations
  • Strong understanding of global regulatory agencies, submissions processes, and applicable regulations and guidances
  • Experience with submission portals, and document management systems is required
  • Experience in eCTD, NeeS, and Paper Submissions and in Lorenz Docubridge, ISI Tool Box
  • Broad knowledge of regulatory information system (RIM)/electronic document management system (EDMS)
  • Strong critical thinking and problem-solving skills to find and digest information and make timely decisions
  • Ability to manage, prioritize, and operate proactively a multitude of overlapping tasks/responsibilities
  • Ability to be adaptable and detailed oriented while meeting tight deadlines
  • Solid oral and written communication skills

 

Medicago is changing the game!

Our Vision: Medicago envisions a world that is prepared to face any disease

Our Mission: To create and deliver effective responses to new global health challenges.

Our mission is driven by the values of innovation, integrity, collaboration, adaptability, and ownership. These values reflect the spirit and culture that inspire Medicago’s people.

As a pioneer in transient expression and plant-based manufacturing, Medicago has always sought a more effective way to improve human health. With nearly 20 years of experience and wisdom behind us, we are poised to revolutionize the traditional approach to vaccines and therapeutics.

It is important that you are legally entitled to work in the US or Canada at the time the job offer is made to you. You may be asked to provide proof of eligibility.

#LI-SASKIA #LI-REMOTE

Learn more here

Job posted: 2022-07-10