Senior Manager, RA Global Regulatory Strategy

Summary

Join AbbVie as a Senior Manager, RA Global Regulatory Strategy US and Canada and be responsible for developing and implementing regulatory strategic and tactical planning for assigned products. You will ensure that regulatory strategies are effectively implemented and maintained, gather data for filings and responses, and enable product commercialization. Additional responsibilities include serving as a Health Authority liaison, advising internal customers on regulatory issues, and contributing to regulatory submissions. You will also assist in staff development and training, recommend project changes based on expertise, and present regulatory information to cross-functional areas. The position offers a hybrid work model with flexibility for remote work within the U.S. Frequent computer use is required.

Requirements

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related
• 6 years Regulatory, R&D, or Industry-related experience
• Demonstrates excellent negotiation skills, problem solving skills and builds consensus
• Demonstrates 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 regulatory strategies
• 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
• Assure 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
• 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 & execution of the regulatory strategy
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates 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
• 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 within US and Canada regulatory requirements and guidelines and assures complete and timely response 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, guidance, as well as corporate policies and management-related considerations
• 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)

Preferred Qualifications

• Advanced Degree
• Certifications
• 2-3 years in pharmaceutical regulatory activities
• Global regulatory experience
• 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