Director/Sr Regulatory Promotional Compliance
We are looking for a Director/Sr Regulatory Promotional Compliance to be the point person managing the promotional activities for the companies’ pre-and post-launch activities. This company has two major partnerships, two marketed products and a solid future where you will be able to build your career. You will work closely with cross functional teams to be the main contact for OPDP and be heavily involved in promotional compliance projects. You should be solutions-oriented, analytical, and have a high level of intellectual curiosity as it pertains to regulatory development.
Responsibilities:
- Provide Regulation direction and risk evaluation to support commercial and promotional materials
- Review and approve commercial and external communications
- Work with compliance departments to ensure communications developed by MSA comply with applicable laws and regulations
- Provide regulatory direction and risk evaluation to support the Commercial team in its creation of compliant and effective promotional materials and programs
- Review and approve commercial materials for the company’s marketed products
- Collaborate with Regulatory Affairs on claims analysis for pipeline programs
- Collaborate with Regulatory Affairs regarding changes to labeling for approved products
Knowledge and Skills:
- Minimum BA required, advanced degree preferred
- Minimum 8-10 years of regulatory experience in the pharmaceutical industry, including specific experience in advertising and promotional regulatory affairs
- Direct experience launching a commercial brand in a regulatory capacity is required
- Experience working with development teams on target product profiles
- Pre and Post Launch experience
- Experience with FDA review divisions is a plus
- Excellent analytical and interpretative skills, enabling substantive review, synthesis, and insights into reports and data used in promotional regulatory strategy and regulatory submissions
- Effective collaboration with regulatory agencies in previous positions, including OPDP