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Product License Support Manager


New York, NY
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Job Details

A Product License Support Manager will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.

Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.

Members of this team hold responsibility for verifying presence and consistency of required investigator related documents in the electronic Trial Master File facilitating the release of Pfizer sponsored investigational medicinal product. Additionally, following submittal of an initial IND, members of the team have accountability for compilation and submittal of IND Annual Reports. Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer's website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team. Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports. In addition, in support of EEA markets, team members will be accountable for partnering with appropriate vendors in submission of A57 records to the EMA . Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in International markets.


+ Delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.

+ Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations, XEVMPD (A57 submissions), IDMP Projects and scheduled regulatory compliance reporting.

Key Accountabilities:

+ Delivery of Product License Support Portfolio in a timely and quality manner

+ Implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes

+ Participation on global/local teams to complete assignments and tasks within a specific task force/project.

+ Knowledge share and educate personnel as appropriate on agency requirements and guidelines.

+ Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these

+ Utilization support of electronic technologies for submissions and tracking of documentation

+ Development and maintenance of documented procedures and guidelines as necessary

Technical Accountabilities

+ Demonstrated knowledge of CFR as it relates to specific post-market submissions

+ Demonstrated knowledge of/experience with Pfizer Commercial Portfolio

+ Ability to communicate information and analyses to a variety of audiences both verbal and written format

+ Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines.


+ Bachelor's degree required plus relevant experience as below-

+ Demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.

+ Demonstrated ability to function autonomously in a matrix environment.

+ Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems

+ Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.

+ Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.

**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.

**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.

**Other Job Details**

+ **Last Date to Apply for Job: December 8, 2017**

+ Additional Location Information: New York, NY and Collegeville, PA.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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