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Director, Regulatory Strategist

Pfizer


Location:
San Diego, CA
Date:
10/27/2017
2017-10-272017-11-25
Job Code:
1619144
Pfizer
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Job Details

Job Title Director, Regulatory Strategist

JobID 1619144

Location: San Diego, CA

Description We have an exciting opening for a highly visible Regulatory Strategist role supporting early and late stage development assets. In a Director level position, this individual will serve as a Global Regulatory Lead on multifunctional and key project teams in the oncology therapeutic area, providing regulatory expertise. Activities may also involve regional focus for the US or EU. The incumbent will develop and deliver regulatory strategies for Phase 1 through Phase 4 development stages and manage all regulatory aspects of projects, including the preparation and submission of correspondences and applications to regulatory agencies. They will also act as direct liaison with FDA, EMA and other Health Authorities to facilitate the prompt review and approval of applications. This successful candidate will have deep understanding of the regulatory environment and the ability to communicate priorities to stakeholders.



Other Key Responsibilities:



+ Accountable for leading the preparation of Global Regulatory Strategies and implementation plans (core labels, risk registers) for assigned projects.

+ Partner with project teams and other customers (e.g., Oncology Research Unit/Pfizer Oncology, Regional Commercial Teams) to ensure regulatory contributions (Global Regulatory Strategies, labels, INDs, CTAs, BLAs/NDAs, MAAs, sNDAs, etc.) meet business needs and are provided within agreed time, cost and quality standards.

+ Develop and maintain constructive working relationship with Health Authority contacts.

+ Ensure an aligned regulatory position is reached and communicated for all key issues for assigned projects, and that these regulatory positions supporting the business are championed and communicated.

+ Work closely with other Regulatory Strategists within and across sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

+ Ensure business compliance, and implementation of and adherence to regulatory standards.



Qualifications:



+ BS; higher degree advantageous

+ Prior oncology drug development experience preferred. Immuno-oncology experience beneficial.

+ Proven examples of delivery with demonstrable contribution in global Regulatory activities, including knowledge of IND/CTA, BLA/NDA/MAA and other submission processes.

+ Proven ability to manage complex regulatory issues.

+ Proven ability to consistently deliver within time, cost and quality standards.



**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.



**Additional Offer Details:**



+ T **his job is Pfizer Exempt US Grade: 16**

+ Additional Location Information: La Jolla, CA; New York, NY; Collegeville, PA; Groton, CT; San Francisco, CA; Cambridge (MA)- Remote based; Milan, Italy; Walton Oaks; UK.

+ Eligible for Employee Referral Bonus



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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