Senior Regulatory Strategy Manager, US & Canada

Regulatory Jobs; Cambridge (MA); On-site; USD 140,000 - 200,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead in Cambridge, MA. The role develops and executes regulatory strategy for US and Canada, interfaces with FDA, and coordinates submissions to ensure timely commercial approvals.

The position requires an advanced degree in a relevant field and at least five years of regulatory/R&D experience in a complex, matrix environment. Strong negotiation and communication skills are essential.

Qualifications

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry-related experience.
• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels 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 and interfacing with government regulatory agencies.

Responsibilities

• Serves as Health Authority 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

Problem solving

Communication

Cross-functional

Regulatory strategy

Education

Advanced degree (PharmD/PhD/MS) or Regulatory certification

Job description

AbbVie is seeking a Senior Manager, Regulatory Affairs US & Canada Strategy Lead in Cambridge, MA. The role develops and executes regulatory strategy for US and Canada, interfaces with FDA, and coordinates submissions to ensure timely commercial approvals.

The position requires an advanced degree in a relevant field and at least five years of regulatory/R&D experience in a complex, matrix environment. Strong negotiation and communication skills are essential.