Job description
Mantell Associates is currently partnered with a leading Global CRO on an exciting opportunity available for a Director of Regulatory Affairs.
Are you looking to join a dynamic and innovative CRO?
Do you have extensive experience in regulatory affairs within the pharmaceutical industry?
Do you enjoy leading and mentoring a team of regulatory professionals to ensure compliance with global regulations?
This company is focused purely within the Neurosciences space in early phase trials. They are looking for a Director of Regulatory Affairs who will be responsible for leading the development and implementation of regulatory strategies for pharmaceutical products in development.
Director of Regulatory Affairs Responsibilities:
Develop and execute regulatory strategies to support the development and approval of pharmaceutical products
Manage and mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies
Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval
Lead the preparation and submission of regulatory filings, including INDs, NDAs, BLAs, and marketing authorization applications
Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations
Director of Regulatory Affairs Requirements:
Bachelor's or advanced degree in a scientific or medical field
Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry, with at least 5 years in a leadership role
Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval
Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals
Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders
Experience with preparing and submitting regulatory filings, including INDs, NDAs, BLAs, and marketing authorization applications
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Stephanie Moreno at 786-431-3404 or stephanie.moreno@mantellassociates.com.