Associate Director, Regulatory Affairs
POSITION OBJECTIVE: Promotional Material, Regulatory Affairs Leader who will direct the OPDP/Add-Prom review and approval process. This position will collaborate heavily with the commercial team preparing to launch oncology drug products.
Essential Job Functions/Responsibilities
· Propose and design well-informed global regulatory strategies for drug product applications and drug product promotional material
· Perform review of promotional material review for FDA regulated drugs
· Represent Regulatory Affairs on review of promotional materials and provide regulatory guidance to Athenex Marketing and partners (e.g. marketing agencies, graphic designers)
· Manage the preparation of global regulatory submissions including OPDP submissions, and responses to regulatory agency questions to support drug product marketing campaign activities.
· Write regulatory documents to support regulatory submissions
· Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
· Establish relevant processes and procedures to support the Regulatory Affairs function activities
· Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
· Ensure compliance with regulatory requirements
Required Education & Qualifications
· Bachelor's degree in life sciences required; advanced degree preferred
· Minimum of 10 years pharmaceutical industry experience with a minimum of 8 years in Regulatory Affairs
· Experience managing global CTA submissions
· Demonstrated evidence of writing regulatory documents
· Knowledge of FDA and ICH regulations and guidelines a must
· Knowledge of promotional material requirements
· Knowledge of EU and regulations and guidelines desirable
· Knowledge of drug development desirable
· Excellent written and oral communication skills
· Excellent interpersonal skills
· Strong project management skills and drive for excellence
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.