Associate Director of Regulatory Affairs
Athenex, Inc., a specialty oncology pharmaceutical company, focuses on the development and commercialization of next generation therapies for cancer diseases and supportive therapies.
Athenex is currently expanding its Regulatory team and is searching for a Assoc. Director, Regulatory Affairs. This individual will operate in a high visibility role and will be responsible for managing the company’s compliance systems and proprietary post approval activities. This position reports to the Vice President, Regulatory Affairs.
Essential Functions and Duties
·Propose and design well-informed global regulatory strategies for post approval changes.
·Lead the company’s compliance systems for Sunshine Act and the Pharma Code / HCP interactions.
·Manage the preparation of global regulatory post approval submissions including IND amendments and annual reports and NDA supplements and annual reports.
·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 post approval regulatory requirements.
·Ensure compliance with the Sunshine Act, HCP interaction requirements and post approval regulatory requirements.
Skills and Experience
·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 regulatory submissions
·Demonstrated evidence of writing regulatory documents
·Knowledge of FDA and ICH regulations and guidelines a must
·Knowledge of EU and regulations and guidelines desirable
·Knowledge of pharmaceutical post approval regulatory requirements
·Knowledge of the Sunshine Act and reporting to CMS and the Pharma Code
·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.