Regulatory Manager (Boston, MA; Dallas, TX; New York, NY; San Francisco, CA)

• →Develop and implement regulatory strategies to facilitate the timely approval of clinical trial applications, product registrations, and other regulatory submissions.
• →Lead the preparation, review, and submission of regulatory documents to agencies such as the FDA, EMA, and other global health authorities.
• →Ensure regulatory compliance throughout product development, clinical trials, and post-market activities, keeping up-to-date with changing guidelines and industry standards.
• →Communicate with regulatory agencies to address inquiries, resolve issues, and ensure smooth progress of submissions and approvals.
• →Oversee and coordinate cross-functional project teams to compile data for regulatory submissions and manage timelines for all regulatory deliverables.
• →Provide strategic guidance on regulatory requirements and best practices to internal teams, including clinical, quality, and product development.
• →Monitor and track the status of regulatory submissions and approvals, providing regular updates to stakeholders and ensuring adherence to deadlines.
• →Manage and maintain regulatory documentation systems, ensuring accurate archiving and tracking of all regulatory activities.
• →Support internal and external audits and inspections to ensure ongoing compliance with regulatory standards.
• →Contribute to the continuous improvement of regulatory processes and systems to enhance efficiency and effectiveness.

• Bachelor’s degree in life sciences, pharmacy, health sciences, or a related field; advanced degree preferred.
• 5+ years of experience in regulatory affairs within the pharmaceutical, biotech, or medical device industries.
• In-depth knowledge of regulatory guidelines and submission processes, with experience dealing with global regulatory agencies (e.g., FDA, EMA).
• Strong leadership and project management skills, with the ability to effectively manage multiple projects and prioritize deadlines.
• Excellent written and verbal communication skills, with the ability to build relationships with regulatory bodies and cross-functional teams.
• Detail-oriented and analytical mindset with strong problem-solving abilities.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and experience with regulatory software or databases is preferred.

Locations:
This position is open to candidates in multiple locations.

This is a contract position