Job Description
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.
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Job Tags
Permanent employment,