Manager / Sr. Manager Regulatory Affairs
Job Title: Manager / Sr. Manager Regulatory Affairs Date:
Department/Number: Regulatory Affairs / 500
Position reports to (job title): Sr. Director, Regulatory Affairs
Summary of Position:
This position will be responsible for providing review and direction for product and disease communications and activities by interpreting current FDA regulations to ensure truthful and non-misleading communication to the health care community, patients, and the public. Additionally, this position will support the regulatory affairs department pharmacovigilance efforts.
Primary Responsibilities and Duties:
Lead Promotion Review Committee (PRC) review of promotional pieces.
Independently review and approve promotional materials using knowledge of promotional regulations and guidance’s, and understanding and application of clinical data for approved products
Develop and communicate the regulatory promotional position for approved products. Completely explain analysis of promotional pieces, must be able to identify evidence gaps and explain claims to be supported by available data. Submit final materials to regulatory authorities.
Develop and execute Medical Affairs, Speaker Training, Advertising Agency and Regional Medical Liaison training on Promotional regulations
Respond to call center inquiries: Provide verbal and written clinical and technical information (FAQs) to internal and external customers for Zogenix products.
Work with Investor Relations and Medical Communication to assist in the development of product Q & As.
Monitor medical and scientific literature for published articles relevant to the safety profile for assigned products
Manage and submit periodic safety reports for assigned products
Education and/ or Experience Required:
• Bachelor’s degree with 5-7 years experience in Regulatory Affairs or MS/MSN with 4-6 years experience.
• Prior Industry experience in promotional review and Medical Information strongly preferred, as well as proven scientific literature analysis and evaluation skills
• Knowledge of FDA regulations regarding promotional activities, medical affairs and drug safety reporting.
• Working knowledge of drug development, IND and NDA process and submissions.
• Superior scientific writing skills for developing regulatory documents.
Skills Required
Language:
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization.
Other:
• Knowledge of Microsoft Office Applications (Word, Excel, and Power Point).
• Excellent verbal and presentation skills.
• Ability to work effectively with Marketing, Legal and Medical departments, and senior management.
• Ability to handle and work under stressful situations with short timelines.
• Ability to manage multiple high priority projects simultaneously.
• Ability to respond quickly to ad hoc requests.
