Regulatory Affairs Manager

Summary

The Sr. Manager, Regulatory & Compliance will ensure all facilities and business entities maintain full compliance with all applicable federal and state regulatory requirements and guidelines for the manufacture, storage, distribution, marketing and sales of products and services. The Sr. Manager, Regulatory & Compliance will work with federal, state, and local regulatory agencies on registrations, licenses, and reporting related to products and services. The Sr. Manager, Regulatory & Compliance will assist the VP Quality & Compliance with the design, administration, and maintenance of Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures.

Experience

Bachelor’s degree with a minimum 10 years of experience in pharmaceutical regulatory & compliance operations, and 2 years of Supervisory experience required.

General Duties And Responsibilities

• Manage federal registrations, licenses, and regulatory reporting to FDA, DEA, and other applicable federal agencies.
• Manage US State licenses and applicable state reporting for pharmaceuticals, controlled substance, price transparency, etc. as required by state regulations.
• Responsible for the oversight and management of GSMS contracted state registered agents.
• Responsible for management and oversight of GSMS National Drug Code (NDC) directory.
• Responsible for management and oversight of GSMS Structured Product Labeling (SPL)
• Responsible for Regulatory & Compliance professional certifications and memberships, such as National Association of Boards of Pharmacy (NABP), Pharmaceutical Product Stewardship Work Group (PPSWG), etc.
• Responsible for the design, implementation, and maintenance of GSMS Regulatory Intelligence Framework to ensure continued compliance with new federal and state regulations and regulatory trends.
• Develop, implement, and maintain policies and procedures related to new GSMS business opportunities to ensure compliance with applicable federal and state regulations.
• Responsible for GSMS corporate compliance and healthcare compliance programs for items such as ethics, fraud, anti-kickback, conflict of interest, HIPPA, US federal Sunshine Act, state disclosure, etc
• Responsible for the compliance and accuracy of GSMS promotional activities and materials.
• Create, execute, and monitor GSMS Compliance Training Program, including the development of role-based training curriculum and training content.
• Assists the VP Quality and Compliance with the design, administration, and maintenance of GSMS Corporate Compliance Plan, Code of Conduct, and associated Compliance Policies & Procedures.
• Responsible for the execution of the Corporate Compliance Committee under oversight of the VP Quality & Compliance.
• Responsible for ensuring Compliance Policies and Procedures are compliant and up to date with applicable regulations.
• Own and execute GSMS Corporate Audit Program to ensure compliance with all applicable regulations and corporate policies/procedures.
• Provide supervision, coaching, development and performance reviews for corporate regulatory/compliance staff
• Participates in special projects and performs other duties as assigned.

Required Qualifications

• In-depth understanding of the pharmaceutical industry with expertise in the body of laws and regulations impacting pharmaceutical companies.
• Knowledge of federal & state regulatory requirements concerning the manufacture, storage, and distribution of pharmaceuticals and dietary supplements.
• Knowledge of current FDA regulations for NDC’s, SPL’s, GDUFA, Cares Act and related reporting requirements.
• Expertise with healthcare industry laws and regulations, including the U.S. Physician Payments Sunshine Act, False Claims Act and Anti-kickback Statute
• Excellent written and verbal communication skills for both internal management and external organizations such as regulatory agencies and customers.
• Ability to read, analyze, and interpret regulations, legal documents, technical journals, clinical and medical terminology, and complex documents.
• Excellent analysis and problem-solving skills
• Excellent organizational skills with extreme attention to detail
• Ability to multi-tasking is essential for this position.
• Ability to lead and manage complex projects.
• Ability to partner effectively
• Strong ability to influence
• Self-motivated and goal-driven
• Ability to work in a team environment.
• Proficient in Microsoft Office applications

Miscellaneous Requirements

• Must be able to pass screening, drug test and background check.
• Adhere to company’s drug-free workplace policies.
• Maintain a strong attendance record

Pay and Benefits

The pay range for this position is $50.00 - $67.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Camarillo,CA.

Application Deadline

This position is anticipated to close on Mar 31, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $67