Senior Director Regulatory Advertising & Promotions
We are looking for a Senior Director of Regulatory Affairs be the primary regulatory reviewer for all external facing communications impacting the company’s marketed products and multiple pipeline programs. This company has two major partnerships, marketed products and a solid future where you will be able to build your career. You will be the primary point of contact with OPDP as well manage promotional Review Committee meeting in support of pre-launch activities. Their discovery and development processes generated a product that’s approved in the United States and ROW as well as a robust pipeline. You should be solutions-oriented, analytical, and have a high level of intellectual curiosity as it pertains to regulatory development.
Responsibilities
- Responsible for regulatory practices and procedures to support compliant commercialization of marketed products and planning for pipeline products.
- Provide regulatory guidance to ensure the company implements commercial programs that comply with all applicable laws, rules and regulations, the company’s code of conduct, policies, and that are consistent with good science and ethics
- Lead the regulatory review and approval of commercial materials and activities
- Provide regulatory direction and risk evaluation to support the commercial creation of compliant and effective promotional materials and programs
- Collaborate with New Product Planning division on claims analysis for pipeline programs
Knowledge and Skills
- Minimum BS in scientific discipline required
- A minimum of 12 years of regulatory experience in the pharmaceutical industry, including specific experience in promotional Regulatory Affairs, with direct experience launching at least 2 commercial brands
- Must have direct consumer experience
- Must have experience ensuring external and internal materials are compliant with rules and regulations
- Experience with other “brands” a plus
- Must have good judgment and communication skills
- Experience managing people