Global Regulatory Lead

4 days ago


Waltham, Massachusetts, United States AbbVie Full time
Job Description

AbbVie's Mission

AbbVie is committed to discovering and delivering innovative medicines and solutions that address serious health issues today and tomorrow.

We strive to have a remarkable impact on people's lives across key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Job Summary

The Director Regulatory Affairs Global Regulatory Lead will develop and implement global strategies to secure and maintain market approval for products in assigned therapeutic areas.

Leads the Global Regulatory Product Team (GRPT) and expands TA knowledge to ensure strategic messaging and content of global regulatory dossiers.

Key Responsibilities

  1. Develop and implement global regulatory strategies to secure and maintain market approval for products in assigned therapeutic areas.
  2. Lead the Global Regulatory Product Team (GRPT) and expand TA knowledge to ensure strategic messaging and content of global regulatory dossiers.
  3. Proactively anticipate and mitigate regulatory risks and ensure compliance with global regulatory requirements.
  4. Manage compounds through all phases of development, including post-approval and throughout the life cycle of the product.
  5. Manage projects and necessary documentation of reg strategies.

Requirements

7+ years of regulatory experience, with some portion related to pharmaceutical regulatory work.

Proven 5+ years in a strategic leadership role with strong project management skills.

Experience interfacing with major government regulatory agencies.

Experience developing and implementing successful global regulatory strategies.

Preferred Qualifications

10+ years of experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions, including the US, EU, or Japan.

Strong global drug development foundation with business acumen.

AbbVie's Commitment

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.

We follow company policies and procedures for regulatory record keeping and ensure alignment of global regulatory strategies with Sr. Management.

Benefits

We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.



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