Regulatory Affairs Consultant – Submissions Manager

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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