A Top Consumer Goods company in New Jersey has retained Junto HLS to recruit a Head of Healthcare Regulatory NA to oversee 10 regulatory affairs professionals (across RA disciplines), a line of top OTC brands and a line of Vitamins, Minerals and Supplements which were recently acquired for over $1 Billion.
The Director will provide a leadership role in interacting with the FDA and other regulatory agencies, planning and implementing regulatory strategies for submission and marketing, providing regulatory strategy while working closely with global teams, providing leadership and guidance on regulatory issues affecting the business and business development opportunities, managing regulatory staff, regulatory training, and serving as an advisor and approver of labeling, promotional activities/materials and other marketing compliance related activities. He/She will utilize varied internal and external resources to develop and execute regulatory strategies for product development to secure product approvals for new product portfolio and be responsible for all regulatory submissions for the United States.
Essential Duties and Responsibilities:
- Manages resources and regulatory staff to deliver on projects and corporate initiatives to achieve strategic business goals
- Establishes regulatory objectives and oversees multiple projects and activities
- Interacts and works collaboratively with multidisciplinary North American and global teams to create product development plans that identify regulatory risks and mitigation strategies for regulatory registration and product marketing
- Leadership role in the interactions with the FDA on regulatory submissions and clinical development plans for product lifecycle; ensures that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.
- Provide leadership and guidance to regulatory staff and colleagues on issues related to regulatory affairs and drug development
- Represents company at regulatory agency and industry meetings
- Provides regulatory strategy and intelligence for due diligence and other corporate issues with full awareness and guidance from current regulations
- Provides regulatory support for analysis of business development opportunities
- Bachelor’s in a scientific discipline and a Master’s, Doctorate, MBA or JD desired
- 7-10 years experience in regulatory affairs within the OTC, VMS or prescription drug industry required
- Must have a proven track record of product approvals and have made significant personal impact/contributions to the approval of new products
- Must have proven ability to lead highly effective interactions or interactions with regulatory agencies
- Must have strong management and leadership skills along with strategic thinking ability
- Must have ability to work in a team environment cross functionally with sales, marketing, sales, and supply, R&D, medical and global.
- Global regulatory experience and experience with Canadian regulations a plus
- Experience with electronic filings (eCTD)
- International regulatory experience
- Northern NJ
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.