Regulatory Affairs Role - Biosimilars

Job Responsibilities:

1. Due diligence activities for new opportunities. Review and advise on adequacy of dossiers/information/data provided in support of new in-license biosimilar submission opportunities for the Biologix portfolio, from the regulatory perspective.

2. Prepare and submit high quality regulatory submissions for biosimilar products in line with targeted project timelines.

3. Interact with internal and external partners as necessary to ensure the appropriate information is obtained for submission.

4. Create, manage and maintain detailed regulatory submission timelines to ensure that all elements of submission dossier are completed in a timely manner.

5. Coordinate with relevant internal and external subject matter experts and external partners to respond to regulatory agency deficiencies.

6. Life Cycle management: perform change control assessments, and prepare/submit necessary post approval change submissions.

7. Ensure that post approval submissions are prepared and filed in compliance with the relevant regulatory requirements and within scheduled timeframes.

8. Support product launch activities from regulatory perspective.

9. Accurately scope out length and difficulty of tasks and projects and ensure timely management of projects and other deliverables.

10. Keep abreast of changes in regulatory requirements.

Job Description

11. Establish and maintain professional standards of communication with colleagues within and outside.

12. Work as a member of a team to achieve all outcomes.

13. Perform all work in accordance with all established regulatory and compliance and safety requirements.

14. Perform other duties as assigned by the Associate Director, Regulatory Affairs.

Job Requirements:

- MSc or PhD in Chemistry, Chemical Engineering, Biotechnological Process Engineering, Molecular Biology or similar.

- Minimum 5 years experience in the pharmaceutical industry with focus on Biologics (specifically in regard to analytical similarity, process development and/or manufacture, immunogenicity), dossier development and technical writing

- Detailed knowledge of Canadian biosimilar regulatory requirements is preferred. Knowledge of regulatory requirements for biosimilars in multiple jurisdictions is an asset e.g. TPD, FDA, EU,etc.

- Excellent oral/written communication, leadership, organizational and interpersonal skills

- Computer literate. Familiarity with IT systems, e.g. electronic submission systems like Docubridge