About The Role

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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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