Regulatory Strategy Lead, US & Canada – Neuroscience

AbbVie; North Chicago (IL); Hybrid; USD 125,000 - 237,000; Full time

Job summary

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead to drive regulatory strategy for on-market and development programs in the Neuroscience area. This role collaborates with the Global Regulatory Lead and interfaces with FDA to support filings, inquiries, and registrations, ensuring timely regulatory responses and compliant submissions.

Ideal candidate holds an advanced degree or regulatory certification with 5+ years of experience, strong negotiation and communication

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.
• 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.

Responsibilities

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development & execution of the regulatory strategy.
• Serves as Health Authority (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.
• May assist in the training of junior 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, 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).
• Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Skills

Negotiation

Regulatory strategy

Regulatory submissions

FDA liaison

Communication skills

Education

Advanced degree or Regulatory certification

Job description

AbbVie seeks a Senior Manager, Regulatory Affairs US & Canada Strategy Lead to drive regulatory strategy for on-market and development programs in the Neuroscience area. This role collaborates with the Global Regulatory Lead and interfaces with FDA to support filings, inquiries, and registrations, ensuring timely regulatory responses and compliant submissions.

Ideal candidate holds an advanced degree or regulatory certification with 5+ years of experience, strong negotiation and communication