Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device
$141,500–$268,500 year
HybridNorth Chicago, Illinois, United States
Job Summary
Develop and implement US and Canada regulatory strategic and tactical planning for assigned on-market and development products. Lead total product lifecycle activities, including change assessments, post-approval requirements, and Health Authority information requests. Manage interfaces with FDA review division personnel, coordinating briefing packages and responses for key projects. Advise internal customers on Regulatory and FDA issues across Public Affairs, Clinical Development, and Legal. Coordinate and supervise regulatory submissions consistent with US and Canada guidelines, ensuring timely responses during application review. Operate independently to plan operations workflows and assignments within the area of responsibility.
Required Qualifications
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
- Minimum 7 years Regulatory, R&D, or equivalent industry-related experience
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization
- Extensive experience interfacing with government Agencies and Health Authority personnel
- Able to deliver challenging messages effectively without compromising important business relationships
- Experience working in a complex and matrixed environment
- Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada device or combination product (device primary) experience preferred)
- US Class III device experience and familiarity with manufacturing processes/change control assessments is preferred
- Demonstrated, forward-thinking strategic experience to accelerate programs or establish regulatory precedence using novel approaches is a plus
- Global regulatory experience is a plus
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.