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.