Senior Manager, RA Global Regulatory Strategy

Summary

Join AbbVie as a Senior Manager, RA Global Regulatory Strategy, US & Canada, and be responsible for developing and implementing regulatory strategies for oncology products in the US and Canada. You will collaborate with Health Authorities, advise internal teams, and ensure compliance with regulations. This role requires strong negotiation, problem-solving, and communication skills. The ideal candidate will have significant regulatory experience and a deep understanding of US and Canadian regulations. The preferred location is Lake County, Illinois, but remote work within the US is possible. AbbVie offers a comprehensive benefits package.

Requirements

• Have a Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry-related
• Have 6 years of Regulatory, R&D, or Industry-related experience
• Demonstrate excellent negotiation skills, problem-solving skills, and build consensus
• Demonstrate effective communication skills in written and oral channels both within Regulatory and across the organization
• Be able to deliver challenging messages effectively without compromising important business relationships
• Have proven skill at implementing successful US and Canada regulatory strategies
• Have experience working in a complex and matrix environment

Responsibilities

• Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or those products in development within the Oncology TA
• Ensure that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs
• Identify and gather data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements
• Be responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and support the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy
• Serve as HA liaison and interface with FDA for meetings, teleconferences and coordinate preparation and completion of FDA meeting briefing packages and responses
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial
• Function independently in negotiation and decision-making for project-related issues that have cross-functional impact
• Assist in the development and training of staff members
• Be a key contributor responsible for 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
• Support the regulatory submission and approval process
• Recommend and implement changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations
• Present pertinent regulatory information to appropriate cross-functional areas
• Operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP)

Preferred Qualifications

• Have an Advanced Degree
• Have Certifications
• Have 2-3 years in pharmaceutical regulatory activities
• Have Global regulatory experience
• Have experience interfacing with government regulatory agencies

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs