Manager, Regulatory Operations and Publishing

Our partner is looking for a Manager, Regulatory Operations and Publishing based in the United States. This role plays a critical role in ensuring accurate, compliant, and timely regulatory submissions that support innovative healthcare solutions. It combines regulatory expertise, document management, publishing operations, and cross-functional collaboration within a fast-paced life sciences environment.

About the role

The Manager, Regulatory Operations and Publishing will oversee submission activities, quality control processes, and regulatory publishing standards to support successful health authority interactions. Working closely with Regulatory Affairs, Clinical, Medical Writing, Quality, and external partners, you will help maintain submission excellence across complex programs. The ideal candidate is detail-oriented, highly organized, and passionate about improving processes that enable efficient regulatory operations. This is an opportunity to contribute to meaningful scientific advancements while helping establish scalable regulatory practices.

Responsibilities

• Manage daily regulatory submission operations activities to ensure timely, compliant, and high-quality health authority submissions.
• Prepare, format, and publish complex regulatory documents according to internal standards and regulatory requirements.
• Generate submission-ready PDF documents while ensuring compliance with eCTD requirements and technical specifications.
• Perform detailed technical quality control reviews of regulatory documents and published submission sequences.
• Oversee submission execution activities, including tracking deliverables, coordinating timelines, and assessing submission readiness.
• Collaborate with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve publishing and documentation challenges.
• Coordinate with external submission partners to support accurate and efficient submission delivery.
• Provide technical guidance to authoring teams regarding document templates, formatting standards, and publishing requirements.
• Support reference management activities using tools such as EndNote or similar platforms.
• Maintain regulatory documentation, records, and data within regulatory information management systems.
• Contribute to the development and continuous improvement of regulatory operations procedures, templates, workflows, and quality standards.
• Monitor updates to FDA, ICH, and other applicable regulatory requirements related to electronic submissions and document management.
• Identify opportunities to improve regulatory processes, increase efficiency, and enhance submission quality.

Requirements

• Bachelor’s degree with at least 4 years of experience in Regulatory Operations or a related regulatory function.
• Demonstrated expertise in regulatory document preparation, formatting, PDF publishing, and submission management.
• Strong understanding of eCTD submission structures, PDF specifications, bookmarks, hyperlinks, file naming conventions, and regulatory publishing standards.
• Experience performing technical quality control reviews of regulatory submissions and published sequences.
• Familiarity with regulatory information management systems, including Veeva Vault RIM preferred.
• Experience with Accenture StartingPoint Templates preferred.
• Strong proficiency in Microsoft Word formatting and document management.
• Excellent attention to detail with a strong focus on accuracy, consistency, and compliance.
• Ability to manage multiple submissions, priorities, and deadlines in a dynamic environment.
• Strong troubleshooting skills with the ability to resolve complex formatting and publishing issues.
• Ability to work independently while effectively collaborating with internal teams and external vendors.
• Excellent communication and interpersonal skills with a professional and proactive approach.
• Strong ethical standards, integrity, and commitment to maintaining confidential information.

Benefits

• Competitive annual salary range of approximately $134,505 - $162,988 USD, depending on skills, experience, location, and other job-related factors.
• Potential eligibility for additional incentive compensation opportunities.
• Remote work flexibility within the United States.
• Comprehensive health coverage, including medical, pharmacy, dental, and vision plans.
• Wellness programs and employee assistance resources to support overall well-being.
• Retirement benefits, including a 401(k) plan.
• Financial protection programs including disability, life insurance, accident insurance, and supplemental coverage options.
• Paid time off, company holidays, and additional leave programs for eligible employees.
• Parental, caregiver, medical, bereavement, and military leave support.
• Volunteer time opportunities and employee engagement programs.
• Opportunities to contribute to innovative healthcare solutions and impactful scientific advancements.
• Professional growth opportunities within a collaborative and multidisciplinary environment.