Director/Assc Director, Regulatory Affairs (Commercial Products) – RTP Area/Top Dollar
Our client, a successful and expanding Raleigh-based pharmaceutical company, is actively recruiting for a very sharp and knowledgeable Regulatory Affairs leader, with particular strength in marketed products, to assume key role on its management team.
This company has multiple products on the market (including co-promotes), two immediate launches planned, and additional launches expected. Commercial operations are expanding exponentially and it is essential that Regulatory Affairs matters are handled impeccably. We seek an industrious and knowledgeable candidate who will drive this effort.
Key Things to Note:
- Role will involve running all aspects of Regulatory Affairs strategy, submissions and life cycle management. We seek a broadly-skilled candidate with substantial experience in all.
- This Director/AD will represent Regulatory Affairs on the Promotional Review Committee. Seek candidate with substantial knowledge of Advertising and Labeling regulations and practices.
- This is an emerging company in which policies, procedures and practices are being developed and enhanced. We seek a make-things-happen builder with an eye for process improvement.
- This Director/AD will regularly collaborate with many departments and executives, some with competing perspectives. Seek adept communicator who effectively develops and delivers smart and compliant solutions.
- This position will begin as an individual contributor. We seek a hands-on Director.
This is a critical role and Company will pay industry leading wage to attract and retain a star.
- Contributes to the development of US regulatory strategies for commercial products and development products
- Identifies, monitors and resolves regulatory issues and reports progress to management
Life Cycle Management
- Leads the planning, execution and assessment of product life cycle management activities and strategies for assigned products
Regulatory Submissions (INDs/NDAs)
- Monitors regulatory submission activities and reviews regulatory documents prior to submission to ensure overall quality, compliance and timeliness
- Partners with project teams to assess regulatory support needs and aligns resources to provide support
Interfacing with Authorities
- Acts as the point of contact with regulatory authorities for assigned products
- Leads calls and meetings with regulatory authorities
- Serves as the primary contact with the FDA Office of Prescription drug Promotion (OPDP) for assigned products
Labeling and Promotional Material Review
- Ensures all materials are consistent with FDA advertising and labeling regulations and guidance (e.g., fair balance, adequate substantiation of evidence, consistency with approved labeling and not false or misleading) and other regulatory enforcement trends, and OPDP guidance, such as OPDP enforcement letters, as well as consistency with any OPDP advisory comments, and advises on enforcement trends
- Submits final promotional materials to OPDP on or before first use (Form 2253 submission)
- Advises on the development of product and disease state communication materials across multiple functional areas: including Corporate Communications, Health Economics and Outcomes Research, and Medical Affairs.
Selected candidate will offer a related life science degree (advanced degree preferred) and 8+ years in Regulatory Affairs roles, with particular strength in marketed products. Launch experience is preferred.
Other priorities include:
- Substantial knowledge of relevant drug laws, regulations and guidances/guidelines
- Experience interacting with the FDA
- Experience with Promotional Material Review
- Experience developing regulatory strategies in coordination with clinical plans and marketing objectives
- Experience in successfully leading teams and the ability to broadly represent RA functions on project teams
- Demonstrated ability to work effectively in a matrix team across multiple disciplines
- Longevity and impact in previous roles
In addition, we seek a collaborative and mission-driven self-starter who will thrive in this dynamic, innovative and entrepreneurial setting. A lot is happening, and we seek a focused go-getter who will contribute broadly.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only at this time.