Associate Director, Regulatory Affairs US & Canada Strategy Lead Facial Aesthetics - Device

About the role

This individual develops and implements US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or those in development. They must combine knowledge of scientific, regulatory, and business issues to enable the development and commercialization of products that comply with relevant US and Canada regulatory requirements.

Responsibilities

• Demonstrate the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.
• Affirmatively assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT) are effectively implemented and maintained in line with changing regulatory and business needs.
• Lead the total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategic support.
• Provide direction and technical insight when necessary to ensure real-time guidance.
• Manage interface with Health Authorities (FDA) for key projects/issues, including direct collaboration with review division personnel.
• Serve as primary liaison and interface with FDA for meetings, teleconferences, and coordinate preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communications on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others.
• Operate independently, with recognition of when to consult management. Make decisions and plans for operations workflow, assignments within area of responsibility with minimal direction.
• Assist in the development, training, and mentoring of junior staff members.
• Coordinate, prepare and/or supervise the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assure complete and timely response to Health Authorities during application review.
• Ensure application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Broadly apply regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory.
• Present pertinent regulatory information to appropriate cross-functional teams.
• Operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Requirements

• Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with minimum 7 years of Regulatory, R&D, or equivalent industry-related experience.
• 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 Canadian 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.

Qualifications

• Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with minimum 7 years of Regulatory, R&D, or equivalent industry-related experience.
• 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 Canadian 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.

Skills

• Strong understanding of current US and Canada regulations and guidance.
• Knowledge of the political and legal climate and industry practices to assist in meeting organizational goals.
• Ability to apply regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Strategic thinking and forward-thinking approach to regulatory matters.

Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
• Participation in long-term incentive programs.

Pay

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.

Schedule

N/A

Benefits

• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).
• Participation in long-term incentive programs.

Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X, and YouTube.