Controlled Substance Apac Hub Lead

Why Patients Need You

We're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

The AsiaPac HUB Lead is the central point of contact and SME for Pfizer’s manufacturing and distribution sites (PGS) in the Asia and Pacific region for controlled substances. You will monitor and maintain a high level of compliance of controlled substances regulatory requirements across sites in those areas. You will also be required to manage sites self-assessments programs and gap closure plans and interact with Government Regulatory Officials as required.

How You Will Achieve It
- Actively monitor and ensure compliance with all controlled substance regulations and applicable corporate and site level SOPs.
- Serve as point of contact for inquiries by CSCF and coordinates support for L1, L2 and L3 audits related to Pfizer Global Supply sites within the region through on-site, remote or questionnaire-based audits.
- Ensure that CAPA plans related to audits are closed in a timely manner.
- 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.
- Provide SME support for consulting, signatory of applicable SOPs, maintenance of all required controlled substance licenses.
- Develop, monitor and support PGS site’s Controlled Substances assessment program in the AsiaPac region. Ensure gaps to Corporate standards are documented and closed per PGS sites defined processes and systems.
- Drive consistent compliance with required regulatory agencies regulations, Pfizer policies and procedures across controlled substance sites.
- Monitor compliance with all related Import/Export regulations as they pertain to site’s Controlled Substance distribution.
- Establish & actively manage strong performance-based relationships with CS Network and regulatory agencies, clearly defining compliance expectations for regulatory authorities.
- Lead controlled substance training development for site personnel.
- Oversee inventory accountability and reconciliation for all controlled substances at PGS designated sites.
- Provide input for updating and improving the Corporate Controlled Substance standard and overall program. Ensure PGS sites in the APAC region are knowledgeable and formally trained on the CS Corp Standard and other applicable regulations.
- Providing expert counsel for addressing issues that impact Pfizer’s compliance with controlled substance requirements
- Consulting with Pfizer’s legal counsel where required.
- Identify and act upon opportunities to promote and strengthen Pfizer’s relationship with regulatory agencies, and/or our customers.

Qualifications

Must-Have
- Bachelor’s Degree in related field
- 9+ years of related industry experience in handling-controlled substance matters with regulatory agencies
- Experience working within the Pharmaceutical industry
- Experience leading a dispersed team
- 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
- Ability to think strategically, strong attention to detail and ability to problem solve
- High 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
- Experience interacting with regulatory officials
- Knowledge and experience in receipt, dispensing, manufacturing, packaging, storage, shipping, and destruction of controlled substances (CS) in compliance with 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
- Strong fluency in English

Nice to Have
- Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
- Master’s Degree
- Regulatory experience

This role will require 30% travel.

Regulatory Affairs