Ethics and compliance advisor supporting Enbridge’s energy regulatory governance program. Monitoring regulatory changes, managing compliance systems, and improving governance across business units.
About the role
- Regulatory submissions manager helping Parexel advance global therapies through compliant health-authority filings. Planning, coordinating, and quality-checking complex IND, DMF, and global submissions.
Responsibilities
- Plan, manage, and track regulatory submissions from inception to completion
- Collaborate with the Regulatory Lead to develop comprehensive submission strategies
- Prepare high-quality global submissions, both in-house and via CRO
- Ensure timely delivery of compliant submissions to global health authorities
- Develop and maintain submission timelines, identifying and managing critical path activities
- Provide regulatory operations expertise to cross-functional submission project teams
- Promote and implement best practices for planning, preparation, and delivery of regulatory submissions
- Stay current with evolving regulatory requirements and submission standards
- Advise on submission format, structure, and content to meet global regulatory requirements
- Act as the primary point of contact for project and/or submission teams for major submissions
- Coordinate and lead submission-related meetings and activities
- Facilitate communication between internal teams, CROs, and external partners
- Ensure submissions meet regulatory requirements and internal quality standards
- Implement and maintain quality control processes for submission documents
- Conduct quality checks on submission components and compiled dossiers
- Identify opportunities for process improvement in submission preparation and management
- Contribute to SOP development and implementation related to regulatory submissions
- Participate in initiatives to enhance submission tools and technologies
- Work with Regulatory Affairs, Clinical Development, and Medical Writing
- Liaise with CROs and external partners involved in submission preparation
- Provide guidance and training to team members on submission requirements and processes
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred)
- Minimum of 5-7 years of experience in regulatory operations, with a focus on submission management, including past experience with IND and DMF submissions
- Previous experience with CTAs, NDAs, and BLAs is a plus
- Strong knowledge of FDA and Health Canada regulatory submission requirements and electronic submission formats (e.g., eCTD)
- Experience with regulatory information management systems and document management tools
- Excellent project management skills with the ability to manage multiple complex submissions simultaneously
- Strong attention to detail and organizational skills
- Outstanding written and verbal communication skills
- Proactive and self-motivated with a strong work ethic
- Ability to work effectively in a team environment and lead cross-functional groups
- Excellent problem-solving skills and the ability to adapt to changing priorities
- Strong interpersonal skills with the ability to build relationships across various stakeholder groups
- Commitment to continuous learning and staying current with regulatory trends and technologies
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