Job description
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 EMEA HUB Lead is the central point of contact and SME for Pfizer’s manufacturing and distribution sites (PGS) in the Europe, Middle East and Africa 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 Pfizer Controlled Substance Center Function (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 EMEA 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 EMEA 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
- 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.
- Previous experience in regulatory interpretation of government regulations via compliance and/or regulatory affairs positions
- Experience interacting with regulatory officials
- Ability to analyze and troubleshoot issues, identify CAPAs and proposed actions
- Knowledge and experience in reviewing CS SOPs to ensure CS requirements are met
- Experience working within the pharmaceutical industry preferably leading a dispersed team
- 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 fluency in English
Nice to Have
- Master’s Degree
- Regulatory experience
- Familiar with Good Manufacturing/Good Distribution practices and other regulatory requirements
- Sound knowledge of product lines, processes and associated technologies to effectively facilitate communication with stakeholders
This role will require 30% travel.
Additional Information
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In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
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Please note there is no relocation support available for this position
How to apply
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Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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