• Posted on: Jul 01, 2025
  • Location: Los Angeles, CA
  • Job ID: 26f02979
  • Type: Full Time
  • Category: Management
  • BLS Category: 11-9199.02 - Compliance Manager
  • Posted on: Jul 01, 2025
  • Location: Los Angeles, CA
  • Job ID: 26f02979
  • Type: Full Time
  • Category: Management
  • BLS Category: 11-9199.02 - Compliance Manager

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Join our pharmaceutical client as they onboard their inaugural Regulatory and Compliance Manager. The Regulatory & Compliance Manager will be responsible for overseeing regulatory and compliance activities to ensure alignment with applicable requirements and industry standards. This role involves managing key regulatory processes, supporting internal compliance initiatives, and collaborating with external agencies and stakeholders. The position also plays a role in maintaining and enhancing company-wide compliance programs, policies, and procedures.
Requirements of the Regulatory and Compliance Manager:
  • In-depth knowledge of pharmaceutical regulations, including manufacturing, storage, and distribution requirements

  • Familiarity with FDA regulations such as NDC, SPL, GDUFA, and CARES Act reporting

  • Understanding of healthcare compliance laws (e.g., Sunshine Act, False Claims Act, Anti-kickback Statute)

  • Strong communication skills, both written and verbal

  • Ability to interpret complex regulations, legal and technical documents

  • Excellent organizational skills and attention to detail

  • Strong analytical and problem-solving skills

  • Ability to manage multiple projects and deadlines

  • Effective team leadership and collaboration skills

  • Proficiency in Microsoft Office tools

Responsibilities of the Regulatory and Compliance Manager:
  • Manage federal registrations, licenses, and regulatory reporting with agencies such as FDA and DEA

  • Oversee state licensing and reporting requirements related to pharmaceuticals, controlled substances, and price transparency

  • Manage relationships with state-registered agents

  • Maintain oversight of the National Drug Code (NDC) directory and Structured Product Labeling (SPL)

  • Maintain certifications and memberships with professional regulatory organizations (e.g., NABP, PPSWG)

  • Design and manage a Regulatory Intelligence Framework to ensure compliance with evolving regulations

  • Develop and implement policies and procedures to support new business initiatives in compliance with regulatory standards

  • Lead corporate and healthcare compliance efforts, including areas such as ethics, fraud prevention, anti-kickback, conflict of interest, HIPAA, Sunshine Act, and state disclosure laws

  • Review and ensure compliance of promotional materials and marketing activities

  • Develop and manage a comprehensive Compliance Training Program, including role-specific training content

  • Support administration of the Corporate Compliance Plan and assist in compliance committee operations

  • Conduct internal audits to assess and ensure regulatory and corporate policy compliance

  • Supervise and develop regulatory/compliance team members

  • Participate in special projects and additional duties as assigned

Miscellaneous Requirements:

  • Must pass background check and drug screening

  • Must comply with drug-free workplace policies

Occupational Category: 11-9199.02 – Compliance Manager
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