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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