Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)

About the 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.

About the Role

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or those in development. They ensure regulatory strategies defined within the Global Regulatory Product Team (GRPT) are effectively implemented and maintained in line with changing regulatory and business needs. This role identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that meet relevant US and Canada regulatory requirements.

Responsibilities

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director) in the development and execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
• Serves as Health Authority (HA) liaison and interfaces with the FDA for meetings, teleconferences, and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advises internal customers (e.g., Public Affairs, Clinical Development, Legal, Commercial) who contribute to regulated communication on Regulatory/FDA issues.
• Functions independently in negotiation and decision-making for project-related issues that have cross-functional impact.
• Assists in the development and training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent with US and Canada regulatory requirements and guidelines, ensuring complete and timely responses to Health Authorities during application review.
• Supports the regulatory submission and approval process.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, and corporate policies.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology, or related field).
• 6 years of Regulatory, R&D, or industry-related experience.
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications

• 2-3 years in pharmaceutical regulatory activities.
• Global regulatory experience is a plus.
• Advanced Degree is a plus.
• Certifications are a plus.

Skills

• Excellent negotiation skills, problem-solving skills, and ability to build consensus.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful US and Canada regulatory strategies.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.