Manager, Regulatory Operations Job Description Template
Our company is looking for a Manager, Regulatory Operations to join our team.
Responsibilities:
- Oversee compliant archiving of all regulatory documents with permissions in place for access;
- Manage the review of regulatory submission documents for completeness and quality in accordance with regulatory agency requirements and standards;
- Manage the process from inception to approval;
- Provide functional and technical guidance with respect to submission of clinical trial applications and marketing applications;
- Manage and maintain regulatory information including relevant logs, trackers and archives of regulatory submissions, correspondence and commitments;
- Oversee global publishing and submission process for domestic and international regulatory bodies;
- Manage projects with vendors and contractors to meet schedules and ensure quality;
- Utilize systems and tools for electronic document capture, generation, manipulation, scanning and QC.
Requirements:
- Creative thinker, motivational leader, strong manager;
- Advanced degree in a related field;
- At least 5 years of global drug development and regulatory operations/affairs experience in the CRO, Biotechnology or Pharmaceutical industries;
- Strong team member and collaborative team player;
- Passionate about growing a strong and productive global regulatory operations organization;
- Proven leadership and program management experience;
- Strong communication skills, both oral and written;
- Strong computer skills, project management skills, and a high attention to detail; and.