Manager, Global Regulatory Affairs Strategist

Pfizer New York City , NY 10008

Posted 6 days ago

This role supports primarily US licensed products.

The purpose of this position is to:

  • Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines

  • Develop and implement Regulatory Strategies for assigned projects/products including assurance that project prioritization, submission strategies, labeling, approvals, post-marketing lifecycle management activities, etc., are in place and delivered in accordance with time, cost and quality expectations for all assigned projects.

  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.

  • Direct and/or indirect liaison with regulatory authorities to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.

  • Lead and/or participates in Regulatory Teams for assigned projects/products.

  • Develop and implements regulatory strategies to support/maintain registrations. Maintains product licenses across all product platforms.

  • Understand regulatory environment and communicates priorities to global stakeholders

  • Deliver project /product strategy incl. label, risk assessment, and PRS for assigned projects/products

BASIC QUALIFICATIONS

  • A Bachelor's Degree is required

  • 5-8 years' experience in the pharmaceutical industry with combined experience in regulatory affairs

Other Job Details:

  • Last Date to Apply for Job: October 27, 2020

  • Eligible for Employee Referral Bonus:Yes
  • Additional Locations: Any USA Pfizer site

#LI-PFE

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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Manager, Global Regulatory Affairs Strategist

Pfizer