Senior Manager, Regulatory Affairs US & Canada Strategy Lead Therapeutic Neurotoxins - Hybrid

Responsibilities

• Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or those in development.
• Affirm 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.
• Serve as Health Authority (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.
• Functions independently in negotiation and decision-making for project-related issues that have cross-functional impact.
• May assist in the training of junior staff members.
• Prepares and reviews regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• 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, 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).

Qualifications

• Advanced degree (e.g., PharmD, PhD, MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry-related experience.
• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities.
• 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 affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.
• Global regulatory experience is a plus.

Additional Information

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community. Equal Opportunity Employer/Veterans/Disabled.