Regulatory Manager

Regulatory Manager

We are seeking an experienced and highly motivated Regulatory Manager to join our Regulatory Affairs team. In this role, you will be responsible for developing and executing regulatory strategies to ensure compliance and successful product approvals. You will oversee the preparation and submission of regulatory documents, manage relationships with regulatory agencies, and lead cross-functional teams to support regulatory activities across a variety of projects and therapeutic areas.

Key Responsibilities:

• 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.

Qualifications:

• 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.