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Director, Regulatory Affairs


New York, NY
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Job Details

Job Title Director, Regulatory Affairs

JobID 1039592-1852

Location: New York, NY

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*

Director, US Regulatory Advertising and Promotion will provide strategic support to the review of Advertising and Promotion materials in order to meet the US brand team's objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP), Advertising Promotional Labeling Branch (APLB) standards and Pfizer internal policies.


*Ensure that reviewed promotional Materials are (i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures, including Global REG08*Provide support for potential new product launches; promotional review of launch materials, implementation of OPDP advisory comment submissions and interactions with the Agency*Work independently and recognize when issues need to be elevated to Senior Management*Lead the development of and updates to the Approved Claims List*Monitor and share with RC Members information on material regulatory developments and trends relevant to the RC generally, OPDP issues and a given promotional Material *Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies *Assist with the development of policy and internal guidance*Effectively communicate regulatory issues and concerns to senior governance groupincluding Marketing, Legal and Medical.*Ensure business compliance and implementation of and adherence to Regulatory standards*Regulatory review of any internal and external business communications*Engage in appropriate activities in order to improve the regulatory environment throughAgency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate.*Mentor newer staff members across the varied disciplines across multiple reviewcommittees*Enhance collaboration across a matrixed organization while developing and maintainingconstructive relationships


BS or equivalent is required. Science degree/advanced degree is preferred.Prior Experience Required:* Six years or greater Pharmaceutical experience including significant Advertising & Promotionexpertise. Regulatory Ad Promo and launch experience a plus* Demonstrable experience of effective delivery in complex matrix environment* Strong negotiation and communication skills* Experience interacting with FDA including OPDP and APLB preferred* Commercial Marketing /social digital media experience a plus * Level of the selected candidate will be determined based upon multiple factors includingrelevant education, overall experience, and prior track record

*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.

*Director, Regulatory Affairs*
*New York, New York*

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