Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device
AbbVie
August 22, 2026
Remote friendly (North Chicago, IL)
United States
$141,500 - $268,500 USD yearly
Corporate Functions
Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development.
- Support the Global Regulatory Lead (GRL) in developing and executing the regulatory strategy for products/multiple driver indications within a Therapeutic Area.
- Lead total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, Health Authority information requests, and annual/internal reporting.
- Manage interface with Health Authority (FDA) for key projects/issues; coordinate FDA meeting/teleconference preparations and responses.
- Advise internal customers (Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Operate independently, consulting management when appropriate; plan workflow/assignments with minimal direction.
- Assist in development, training, and mentoring of junior staff.
- Coordinate/prepare/supervise regulatory submissions and ensure complete, timely responses during application review; ensure compliance with US/Canada requirements and best practices.
- Present pertinent regulatory information to cross-functional teams; serve as subject matter expert (SME) for Regulatory.
Qualifications:
- Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent industry-related experience.
- Effective written and oral communication across the organization.
- Extensive experience interfacing with government agencies and Health Authority personnel.
- Negotiation skills, strategic thinking, and credibility.
- Experience in complex, matrixed environments.
- Proven success implementing affiliate regulatory strategies (US/Canada device or combination product experience preferred).
- US Class III device experience and familiarity with manufacturing processes/change control assessments preferred.
- Forward-thinking strategic experience to accelerate programs or establish precedence is a plus.
- Global regulatory experience is a plus.
Benefits (if applicable): Paid time off, medical/dental/vision insurance, 401(k) eligibility; eligible for long-term incentive programs.
- Support the Global Regulatory Lead (GRL) in developing and executing the regulatory strategy for products/multiple driver indications within a Therapeutic Area.
- Lead total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, Health Authority information requests, and annual/internal reporting.
- Manage interface with Health Authority (FDA) for key projects/issues; coordinate FDA meeting/teleconference preparations and responses.
- Advise internal customers (Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Operate independently, consulting management when appropriate; plan workflow/assignments with minimal direction.
- Assist in development, training, and mentoring of junior staff.
- Coordinate/prepare/supervise regulatory submissions and ensure complete, timely responses during application review; ensure compliance with US/Canada requirements and best practices.
- Present pertinent regulatory information to cross-functional teams; serve as subject matter expert (SME) for Regulatory.
Qualifications:
- Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent industry-related experience.
- Effective written and oral communication across the organization.
- Extensive experience interfacing with government agencies and Health Authority personnel.
- Negotiation skills, strategic thinking, and credibility.
- Experience in complex, matrixed environments.
- Proven success implementing affiliate regulatory strategies (US/Canada device or combination product experience preferred).
- US Class III device experience and familiarity with manufacturing processes/change control assessments preferred.
- Forward-thinking strategic experience to accelerate programs or establish precedence is a plus.
- Global regulatory experience is a plus.
Benefits (if applicable): Paid time off, medical/dental/vision insurance, 401(k) eligibility; eligible for long-term incentive programs.