Regulatory Affairs Consultant – Submissions Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee the planning, management, and tracking of regulatory submissions from start to finish.

• Collaborate closely with the Regulatory Lead to formulate thorough submission strategies.

• Generate high-quality global submissions, both internally and through CROs.

• Ensure that compliant submissions are delivered on time to global health authorities.

• Create and maintain submission timelines, while identifying and managing critical path activities.

• Offer regulatory operations expertise to cross-functional project teams involved in submissions.

• Advocate for and implement best practices in the planning, preparation, and execution of regulatory submissions.

• Keep abreast of changing regulatory requirements and submission standards.

• Provide advice on submission format, structure, and content to align with global regulatory standards.

• Serve as the main point of contact for project and/or submission teams regarding major submissions.

• Organize and lead meetings and activities related to submissions.

• Facilitate communication among internal teams, CROs, and external partners.

• Ensure that submissions comply with regulatory requirements and meet internal quality standards.

• Establish and uphold quality control processes for submission documents.

• Conduct quality assessments on submission components and compiled dossiers.

• Identify opportunities for enhancing processes related to submission preparation and management.

• Contribute to the development and implementation of SOPs related to regulatory submissions.

• Engage in initiatives aimed at improving submission tools and technologies.

• Collaborate with Regulatory Affairs, Clinical Development, and Medical Writing teams.

• Coordinate with CROs and external partners involved in the preparation of submissions.

• Provide guidance and training to team members regarding submission requirements and processes.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline (advanced degree preferred).

• At least 5-7 years of experience in regulatory operations, specifically in submission management, including prior experience with IND and DMF submissions.

• Experience with CTAs, NDAs, and BLAs is advantageous.

• In-depth knowledge of FDA and Health Canada regulatory submission requirements and electronic submission formats (e.g., eCTD).

• Familiarity with regulatory information management systems and document management tools.

• Exceptional project management abilities, capable of handling multiple complex submissions concurrently.

• Strong attention to detail coupled with excellent organizational skills.

• Outstanding written and verbal communication capabilities.

• Self-motivated and proactive with a robust work ethic.

• Ability to work efficiently within a team environment and lead cross-functional groups.

• Excellent problem-solving abilities and adaptability to changing priorities.

• Strong interpersonal skills, enabling relationship-building across various stakeholder groups.

• Commitment to ongoing learning and staying informed about regulatory trends and technologies.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements and a supportive work environment.