US Controlled Substance Operations Lead

Use Your Power for Purpose

We are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Navigating the ever-changing regulatory environment compliantly requires forward-thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines.

What You Will Achieve

In this role, you will:

• Provide regional leadership and governance for controlled substance and listed chemical operations across PGS sites in the United States, ensuring alignment with federal and state regulations and applicable global and site standard operating procedures (SOPs).
• Serve as the principal subject-matter expert for the compliant purchase, receipt, manufacture, testing, storage, inventory control, distribution, import/export, reporting, and destruction of regulated materials.
• Lead inspection readiness and coordinate responses to state and federal regulatory inspections, including maintenance of required inspection files, records, registrations, licenses, and regulatory submissions.
• Oversee the Drug Enforcement Administration (DEA) procurement quota process and support state licensing compliance for applicable U.S. sites.
• Lead and support the PGS controlled substance audit program in the United States, coordinate Level 1, Level 2, and Level 3 assessments, and ensure corrective and preventive actions (CAPAs) are robust and closed on time.
• Oversee inventory accountability and reconciliation and provide expert counsel on investigations, theft or loss reporting, compliance gaps, and issues that may affect Pfizer’s ability to manufacture or distribute controlled substances.
• Monitor controlled substance import and export compliance, including required permits and forms and applicable International Narcotics Control Board (INCB) requirements.
• Build effective, compliance-focused relationships with regulatory agencies and internal stakeholders; communicate significant risks, activities, and escalations to relevant Global Supply Chain and regulatory leadership.
• Lead, coach, and develop a geographically dispersed team; establish role-based training and ensure site personnel remain qualified on applicable procedures and regulatory requirements.
• Contribute to continuous improvement of global controlled substance procedures, governance, systems, and operating practices, and represent the region in global, regional, and local forums.

Here Is What You Need (Minimum Requirements)

• BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience or PhD/JD with 1+ year of experience or MD/DVM with any years of relevant experience  
• Proven ability to handle complex and global projects efficiently
• Deep understanding of records management within a regulated environment
• Proficiency in Microsoft Office Suite
• Effective interpersonal and communication skills
• Experience in people management
• Relevant regulatory expertise and business acumen

Bonus Points If You Have (Preferred Requirements)

• A Master's degree (MA/MBA/MS) with 7+ years of experience or a Doctorate (PhD/PharmD/JD) with 4+ years of relevant experience
• Proficiency in Lean and/or Six Sigma methodologies
• Strong background in continuous improvement techniques
• Excellent problem-solving skills
• Strong leadership and team-building skills
• Experience in developing and implementing strategic initiatives
• Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

  
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Up to 30% travel. Periodic schedule flexibility may be required to support site operations, inspections, audits, investigations, and time-sensitive regulatory matters.

Work Location Assignment: Hybrid

Last Date To Apply: September 25, 2026

 

 

The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

 

 

 

 

 

 

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

 

 

Relocation assistance may be available based on business needs and/or eligibility.

 

 

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

 

 

 

 

 

 

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

 

 

Regulatory Affairs