Regulatory Strategist IV
One of the most globally known pharmaceutical corporations is seeking to hire a Senior-level Regulatory Strategist for a 6-month renewable contract for one their NJ locations. This position brings strategic regulatory leadership to North America pipeline projects in the OTC drug, device, cosmetic, food or dietary supplement areas, with an emphasis on US OTC Monographs.
The Regulatory Strategist IV will be responsible for: 1) providing regulatory leadership to North America cross functional project teams, pertaining to OTC Monograph Drug product development and launch, and business development opportunities. 2) Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts within the region. 3) Regulatory review and approval of launch advertising and promotional copy. 4) Lead development of regulated labeling content for new products. 5) Monitor, analyze and advise the business on existing and emerging regulatory trends and requirements.
Duration: 6-month contract
Location: Madison, NJ (100% office-based)
Compensation: $95-102 per hour
- Education: Scientific Bachelor or advanced degree required.
- Minimum of 3-5 years' experience in Rx or OTC Regulatory Affairs is required, consumer products experience preferred.
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.
- Demonstrate the ability to research and analyze information and develop regulatory strategies.
- Must be able to work independently and within a group setting, and to interact effectively with various functional groups.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems is required.
- Able to strategically influence and negotiate with internal and external customers
- High level of attention to detail.
Sthree US is acting as an Employment Business in relation to this vacancy.