Regulatory Affairs Consultant - Submissions Manager

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.

Originally posted on Himalayas