Senior Manager level regulatory affairs position, concentration on postmarketing. Represent Regulatory Affairs on Promotional Review Committee, providing guidance on compliance with FDA laws and regulations regarding marketing of pharmaceuticals and medical products.
Essential Duties & Responsibilities:
- Primarily responsible for Regulatory Affairs activities involving marketed products. Specifically, this party is responsible for:
- Conducting regulatory review and comment on advertising and promotional materials for assigned products, representation of Regulatory on Promotional Review Committee, and oversight of submission of promotional materials.
- First line Regulatory Affairs resource for marketing and sales departments.
- Assisting as needed with postmarketing supplements to marketed product applications.
- Assisting as needed with electronic submission of promotional materials.
- Responsible for Regulatory Affairs aspects of implementation of labeling changes including:
- Package inserts.
- Medication guides.
- Container labels.
- Important safety information.
- Brief summaries.
Non-Essential Duties & Responsibilities:
- Department representative on selected project teams for commercial products; and, for completion of post-marketing commitments.
- May assist with interface with licensees regarding ex-US sales and promotion of commercial products.
- Creation and conduct of interdepartmental educational programs to advance understanding of postmarketing regulations.
- Additional responsibilities upon request, in support of supervisor, including but not limited to:
- Labeling activities.
- Regulatory research.
- Operations and process improvements.
- Due diligence support.
Knowledge & Other Qualifications:
- Minimum 6 years relevant experience in pharmaceutical regulatory affairs.
- Minimum education: Bachelor’s degree, advanced degree preferred.
- Minimum of 2 years of experience with largely independent review of advertising and promotional materials required (recent strongly preferred).
- Medical/pharmacy/clinical science and or medical-legal background strongly preferred.
- Experience with direct interface with FDA Office of Prescription Drug Promotion desirable.
- Experience with neurology therapeutic area desirable.
- Experience with the Microsoft Office Suite.
- Requires excellent interpersonal and good corporate presentation skills.
- Excellent written and verbal communication skills.
- Ability to persuade, influence, and defend position.
- Ability to work independently and as part of a team.
Physical Requirements / Work Environment:
- Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
- The worker is not substantially exposed to adverse environmental conditions.
- Ability to maintain high ethical standards of integrity and quality.
- Capable of being innovative, dynamic, and collaborative in approach to work.
- Capable of performing other duties as assigned by management.
- Authorized to legally work in the United States without visa sponsorship.