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Regulatory Manager (Pharma)

1 day ago
United States
Full-time
Senior
Compliance Manager
Project and Program Management
Apply Now
CG Life

CG Life

CG Life specializes in marketing and communication strategies for the life sciences and healthcare sectors, focusing on the unique challenges associated with rare and hard-to-treat diseases and precision medicine.

Professional Services
51-250
Founded 2003
View All Jobs 5

Description

  • Lead regulatory strategy and execution for the highest-complexity, highest-priority, and most visible submissions.
  • Serve as the primary point of contact for MLR reviews and provide regulatory guidance to internal teams and clients.
  • Develop and maintain regulatory policies, procedures, and training materials for assigned accounts.
  • Review promotional materials for accuracy and compliance with applicable regulations.
  • Track regulatory trends and requirement changes, and help improve internal processes and training.
  • Mentor, develop, and supervise Regulatory Specialists and Senior Regulatory Specialists.
  • Oversee team workload distribution, performance management, and professional development.
  • Collaborate with clients to resolve regulatory questions and concerns.
  • Participate in leadership meetings and report on compliance status and process improvements.
  • Improve MLR review efficiency through streamlined workflows and better communication.

Requirements

  • Bachelor's degree in life sciences, healthcare, communications, English, or a similar field, or equivalent experience.
  • 3+ years of experience with regulatory or legal review processes in healthcare or another regulated industry, or 2+ years of agency experience in a regulatory or editor role, or equivalent client-side MLR-focused experience.
  • 2+ years of supervisory experience, or equivalent education and training.
  • Strong knowledge of FDA regulations and MLR processes.
  • Demonstrated ability to lead teams and manage multiple projects in a fast-paced environment.
  • Successful history of guiding change.
  • Excellent written and verbal communication skills with strong attention to detail.
  • Proficiency with project management and collaboration tools, Adobe Acrobat, and Microsoft Office Suite.
  • Preferred experience in agency settings or working directly with healthcare clients.
  • Preferred working knowledge of Veeva Vault PromoMats or a similar content management and review platform.

Benefits

  • Estimated salary range of $95,000 to $110,000 USD.
  • Eligibility for a discretionary bonus program.
  • Health benefits.
  • 401(k) retirement plan with generous company match and immediate vesting.
  • Flexible time off.

Interested in this position?

Apply directly on the company website

Apply Now

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