Our client is looking to fill the role of Senior Director, Regulatory Affairs.
Responsibilities :
Serve as head for all regulatory activities for US products and to lead, manage and submit regulatory submissions to FDA to include supplements and post-approval reporting of marketed products.Lead all activities related to promotional, advertisements and labeling.Serve as FDA liaison regarding submissions and communications.Lead and manage all eCTD submissions to the FDA.Ensure all regulatory file documentation is compliant with regulatory authority requirements.Manage Certificate of Pharmaceutical Product and Price Certificate requests and legalizations.Responsible for renewing NDA and advice registrations, as well as update listings with the FDA.Manage label design process, adhering to FDA requirements, as well as prepare labeling claim information based on FDA guidance and the performed study.Lead Promotional Review Committee activities.Fully manage all labeling preparation for all marketed products and prepare label listings for the FDA.Collaborate closely with artwork designer on labeling artwork and proof preparation, as well as work with CMO partner to apply for product packaging.Maintain traceability for all promotional materials per regulatory guidelines.Manage all company state license applications for all of US.Collaborate closely with the Director of Compliance in development of the US Compliance Program for the organization.Serve as lead for hosting all regulatory inspections / audits, both internal and external.Requirements :
Minimum of a Bachelor’s Degree in a scientific discipline.10 years of direct, industry -related Regulatory experience in relevant industries with at least 5 years in a leadership Regulatory role.Pharmaceutical industry experience, FDA rules and regulation knowledge, NDA, BLA and post-approval submission knowledge and experience, strong cGMP and CMC experience. Labeling, advertising, and promotional materials.Strong experience in PRC process and FDA regulations.If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https : / / www.solomonpage.com / crn and connect with us on Facebook and LinkedIn
Opportunity Awaits.
Salary : $250,000 - $280,000
