Remote CMC Regulatory Affairs Manager

Jobgether

21h•Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Remote CMC Regulatory Affairs Manager. In this role, you will play a crucial part in shaping regulatory strategies and ensuring compliance with health authority standards. Your expertise will drive the efficiency of regulatory submissions and facilitate collaboration within cross-functional teams. As a key player in the organization, you'll be responsible for addressing client issues and enhancing workflows while maintaining positive relationships with stakeholders. Your contributions will ultimately impact the health sector, promoting better outcomes for patients and animals alike.

Requirements

B.Sc. in Life Sciences or extensive equivalent experience; advanced degree preferred.
Certification in Regulatory Affairs (RAC) is an asset.
Prior consulting experience is preferred.
Comprehensive knowledge of biologic products and related regulatory frameworks.
Proven ability to author regulatory documentation in compliance with standards.
Minimum of 5 years of experience in Canadian CMC regulatory affairs.

Nice To Haves

Certification in Regulatory Affairs (RAC) is an asset.
Prior consulting experience is preferred.
advanced degree preferred.

Responsibilities

Co-ordinate and compile regulatory submissions and responses to agency queries for assigned projects.
Participate in cross-functional teams to support regulatory strategies and business objectives.
Identify client and dossier issues, developing effective solutions while collaborating with colleagues.
Maintain productive liaisons with internal and external contacts including clients and agencies.
Prioritize projects to meet budget, timelines, and client expectations while ensuring quality.
Support client proposals and new business initiatives as required.
Travel as necessary for client-related activities.