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Regulatory Affairs Consultant - Submissions Manager

Primary Location: Canada, Ontario, Remote Job ID R0000044481 Category Regulatory / Consulting Date Posted 08/21/2026

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- Success profile
- About this role
- Employee insights
- Why Consultants work at Parexel
- Learn about our culture

Overview As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic

Back to nav About This Role We are seeking a skilled and experienced Regulatory Operations Submission Manager to join our team. This crucial role involves planning, managing, and tracking regulatory submissions to ensure timely delivery of high-quality, compliant submissions to global health authorities. The ideal candidate will have strong project management skills, expertise in regulatory operations, and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities Submission Planning and Management:

- 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

Regulatory Operations Expertise

- Provide regulatory operations expertise to cross-functional submission project teams




- Promote and implement best practices for excellence in 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

Project Team Leadership

- 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 effective communication between internal teams, CROs, and other external partners involved in submission preparation

Quality Assurance

- Ensure submissions meet all regulatory requirements and internal quality standards
- Implement and maintain quality control processes for submission documents
- Conduct quality checks on submission components and compiled dossiers

Submission Process Improvement

- Identify opportunities for process improvement in submission preparation and management
- Contribute to the development and implementation of standard operating procedures (SOPs) related to regulatory submissions
- Participate in initiatives to enhance submission tools and technologies

Cross-functional Collaboration

- Work closely with various departments, including Regulatory Affairs, Clinical Development, and Medical Writing
- Liaise with CROs and other external partners involved in submission preparation
- Provide guidance and training to team members on submission requirements and processes

Qualifications

- 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 to include past experience with IND and DMF submissions. Previous experience with CTAs, NDAs, 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

Desired Qualities

- 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

If you are a detail-oriented professional with a passion for regulatory operations and a talent for managing complex submission projects, we encourage you to apply for this exciting opportunity to join our team and contribute to the successful delivery of regulatory submissions worldwide.

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Employee Insights How to describe Parexel culture in one word

Insights from Parexel employees

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Jo on diverse project work and team culture

Jo Wang | Vice President, Technical

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Kurt Brorson | Vice President, Technical

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Why Consultants work at Parexel

Patient-led in everything we do

We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects.

Supportive and inclusive setting

We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge.

Opportunities for career growth

We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth.

Flexible work arrangements

We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment.

Diverse and global client exposure

We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval.

Learn from experts

You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career.

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Learn About Our Culture

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- Benefits & Support

At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture.

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- Emerging Talent Opportunities

Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind.

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- Inclusion at Parexel

Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment.

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📌 Regulatory Affairs Consultant - Submissions Manager (Canada)
🏢 ATLAS MEDICAL SERVICES LTD. STI.
📍 Canada