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US Import / Export Regulatory Manager

Pfizer


Location:
Groton, CT
Date:
03/21/2017
Job Code:
1048486-1852
Pfizer
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Job Details

Job Title US Import / Export Regulatory Manager

JobID 1048486-1852

Location: Groton, CT

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

This position reports to the Conformance Office (CO) Lead and develops US import/export strategies and processes for Pfizer Pharmaceutical, BioPharmaceutical, and Consumer Healthcare commercial products related to the movement of API, Finished Dosage Pharmaceuticals and other pharmaceutical materials of value across the Pfizer Supply Chain that ensure compliance with US FDA regulations. Provides regulatory expertise and strategic advice for Pfizer and 3rd party manufacturing sites to ensure import/export activities are compliant with global, corporate, divisional, and regulatory agency requirements. Interacts with FDA as the primary contact for Pfizer import/export issues. Coordinates with appropriate business units in response to Health Authority import/export queries. Monitors import/export issues to provide process improvement opportunities. Monitors broker reports to proactively interact with Regulatory Authorities limiting potential delays in release of import/export materials. Liaises and collaborates with Supply Chain Logistics, PGS, WSR, Legal, 3rd parties, and regulatory agencies in all matters related to import / export FDA regulation compliance.



*Responsibilities*

Develops and implements US import and export strategies, policies and procedural guidelines for all commercial product movement in Pfizer and across third party manufacturing sites.Acts as direct liaison with regulatory authorities to facilitate the prompt release of import/export materials, and to discuss/gain approval for Pfizer import strategies, where appropriate.Maintains current understanding of US import/export regulations, reviews upcoming or potential regulation changes and proposals, provides comments on pending regulation guidance, and drives awareness of these changes across applicable functions within Pfizer and Third Parties.Interacts directly with FDA to support special import/export scenarios (e.g., PLAIRs, pre-approval submissions, use of FTZs).Where appropriate, provides guidance on or directly develops documentation (e.g., End Use letters) required to support FDA release of import/export materials.Monitors and ensures compliance in accordance with all Corporate, Division, and Regulatory Agency requirements for US commercial import/export and other inter-country trade management (including Pfizer and third party manufacturing sites.)Consults and collaborates with all internal Pfizer divisions and functions on US commercial import and export compliance on all import and export matters.Participates in and serves as Pfizer representative in various external teams (e.g., import/export industry teams), internal project teams and Regulatory Agency projects.Develops and maintains strong relationships with FDA to ensure a consistent understanding of regulatory requirements and their understanding of Pfizer's compliance.Contributes to development of Pfizer internal trade compliance training/education (e.g., general awareness training, training specific to individuals/scenarios).



*Qualifications*

Bachelor's degree or equivalent qualifications in Chemistry, Pharmacy or a related life science field.5-8 years' experience in US import / export / trade management, or CMC/Regulatory related areas within the pharmaceutical industry.A minimum of 3 years' experience directly interacting with Health Authorities.Firm knowledge/understanding of CMC Change Management and FDA Import/Export regulations.Strong focus on customer service and demonstrated ability to communicate across all levels of the organization.Training in GMP, Quality processes, ISO9000 experience, and Quality and/or Broker certifications is desired.Knowledge of Warehousing, Distribution, Trade and Customs laws and processes, Production Planning and Capacity Management, Sourcing and Procurement, including 3rd Party Management helpful.Extended Supply Chain Awareness



*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.





*US Import / Export Regulatory Manager*
*Groton, Connecticut*
*1048486-1852*


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