Controlled Substances Americas Hub Lead

Employer
Pfizer
Location
Remote, Oregon
Salary
Competitive
Closing date
Dec 8, 2022

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Sector
Pharmaceutical, Regulatory Affairs
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional
What You will Achieve

The Controlled Substances Americas HUB Lead is the central point of contact for Pfizer's manufacturing sites in the Americas (U.S., Canada and Latin America). Monitor and maintain a high level of compliance of controlled substances regulatory requirements across sites in those regions. Manage sites self-assessments programs and gap closure plans.

Interact with Government Regulatory Officials as required.

How You Will Achieve It

Actively monitor and ensure compliance with all controlled substance regulations at PGS sites in the Americas region through regulations at the federal or state level (US), and applicable corporate and site level SOPs.

Provide SME support to all applicable controlled substance regulations for the site manufacturing, testing, storage and shipment of regulated controlled substances - examples include inventory requirements, maintenance of an inspection file, regulatory inspections support, and support for reporting of theft and losses.

Oversee and manage the DEA Quota process for PGS sites in the U.S.

Serve as point of contact for inquiries by CSCF and coordinates support for L1, L2 and L3 audits of sites within the region through on-site, remote or questionnaire-based audits. Ensures that CAPA plans related to audits are closed in a timely manner.

Provide SME support for consulting, signatory of applicable SOPs, maintenance of all required controlled substance licenses.

Responsible for supporting PGS site's Controlled Substances assessment program in the Americas. Ensure gaps to corporate standards are documented and closed per PGS sites defined processes and systems. Responsible for driving consistent compliance with required regulatory agencies regulations, Pfizer policies and procedures across controlled substance sites.

Responsible to monitor compliance with all related Import/Export regulations as they pertain to site's Controlled Substance distribution. Includes supporting the processing of required forms and knowledge of INCB regulations for movement of such product either prior to import or after export.

Establish & actively manage strong performance-based relationships with regulatory agencies, clearly defining compliance expectations.

Lead controlled substance training development for direct reports and site personnel.

Oversee inventory accountability and reconciliation for all controlled substances at PGS sites.

Provides inputs for updating and improving the Corporate Controlled Substance standard and overall program. Ensure PGS sites in the Americas are knowledgeable and formally trained on the CS Corp Standard and other applicable regulations.

Responsible for:
  • The communication of site Controlled Substances activities to CS Network lead.
  • Providing expert counsel for addressing issues that impact Pfizer's compliance with controlled substance requirements
  • Consulting with Pfizer's legal counsel when legal action is taken against Pfizer for alleged inappropriate actions by Pfizer regarding controlled substance or listed chemical handling.
  • Identifying and acting upon opportunities to promote and strengthen Pfizer's relationship with regulatory agencies, and/or our customers.
  • Managing a team of 5-7 direct reports


Continued compliance with all government regulations is critical in ensuring Pfizer can consistently produce and distribute controlled substances and other prescription products. Failure to effectively support the manufacturing and commercial organizations could have significant implications to short term and long-term business strategies.

Qualifications

Must-Have
  • Bachelor's Degree in related field / Master's Degree preferred
  • Minimum of 9-13 years of related industry experience in handling matters with controlled substance regulatory inspectors
  • Experience leading a dispersed team
  • Experience with controlled substances and listed chemical requirements is required
  • Must have sound knowledge of product lines, processes and associated technologies to effectively facilitate communication with stakeholders
  • Previous experience in regulatory interpretation of government regulations via compliance and/or regulatory affairs positions is necessary
  • Must possess ability to think strategically, strong attention to detail and ability to problem solve
  • Must operate with highest level of integrity, professionalism and exhibit sound judgement at all levels
  • Proficient in MS Office Applications (i.e., Excel, PowerPoint, Word, Outlook)
  • Strong oral and written communication skills
  • Comprehensive/Working knowledge of Drug Enforcement Agency (DEA) regulations with particular emphasis on Schedule II, allcontrolled drugs and listed chemical requirements
  • Experience interacting with State and Federal regulatory officials
  • Knowledge and experience in DEA required records (e.g. DEA Forms 222, 263, 357, 161, etc.)
  • Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with State and Federal regulations
  • Knowledge and experience in conducting CS investigations.
  • Ability to analyze and troubleshoot issues, identify CAPAs and proposed actions
  • Knowledge and experience in reviewing CS SOPs to ensure CS requirements are met
  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
  • 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.


Nice-to-Have
  • Experience working in pharmaceutical industry
  • Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
  • Regulatory experience


Physical/Mental Requirements

Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholders

Non-Standard Work Schedule, Travel or Environment Requirements

Up to 30% travel

Work Location Assignment:Flexible

Other Job Details
  • Last Date to Apply: December 7, 2022


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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Regulatory Affairs

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