1+ months

Director, Global Regulatory

Pfizer
New York, NY 10007
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**The purpose of this role is to:**

Provide strategic regulatory expertise as Global regulatory representative to Product Team(s).

Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional regulatory colleagues from North America, Europe, Emerging Markets, Japan.

Through the GRST, develop, align, manage and implement the global regulatory strategy.

Be accountable for delivering the project goals and aligning the regulatory strategy with global and business regional needs.

Be accountable for timely submissions and approvals with commercially attractive labelling across the regions.

Be accountable for ensuring optimal regulatory interactions with Health Authorities in relation to the assigned project(s).

Role likely to be combined with other Regulatory Role (i.e. regional US or EU regulatory role and/or Regulatory Lead for other projects).

Project(s) assigned can be in development and/or at post-authorization stage.



**ROLE RESPONSIBILITIES**



+ Responsible for the production, updating and communication of global regulatory strategies for assigned projects/ products, mechanisms of action and/or indications.

+ Provides regulatory expertise and leadership for the project/product.

+ Member of appropriate Project(s)/Product(s) teams.

+ In partnership with the Project/Product Team Leader (eg MTL, GCMTL, RPL etc.), accountable for the delivery of the Project/product goals according to the endorsed Global Regulatory Strategy.

+ Ensures appropriate representation for Pfizer for the project/product with Health Authorities.

+ Ensures rapid reporting and dissemination of regulatory agency contact information and project/product communications to appropriate team and colleagues.

+ Ensures that all regulatory development process commitments are clearly communicated, monitored and met.

+ Acts as the point of contact for all internal Pfizer communication regarding the status of the project/product on issues related to regulatory process and registration strategy

+ Mentoring, developing regulatory professionals who are assisting in meeting the project/product objectives.

+ Develop strong and positive working relationships with regulators, professional bodies, external experts, opinion leaders and Pfizer internal and external stakeholders.

+ Ensures rapid reporting of key project/product regulatory milestones and/or issues to the GRPL and other stakeholders as required.

+ Participates in appropriate governance committees, as necessary.



**QUALIFICATIONS**

BS is required. MS, PharmD, PhD or MD preferred. Equivalent workplace experience can be considered.



+ Minimum 10+ years regulatory experience in the pharmaceutical/healthcare industry



Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST.

Advanced knowledge of US FDA and/or EU regulations.

Working knowledge of other regulations and their associated challenges for global development programs.

Direct experience with at least US and/or EU submissions and approvals.

Direct experience in communicating with major regulatory agency(ies) (ie FDA, EMA, Japan), as well as participating in/leading such interactions such as End-of-Phase 2, pre-submission meeting(s).

Understanding of clinical trial design and management, including data flow process.

Experience working in a highly matrixed, global and multi-site environment.

Track record of having supported at least one project of high complexity and provided strategic direction.

Experience within different therapeutic areas and at different stages of products life cycle.



\#LI-PFE



**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.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-08-16 Expires: 2019-11-21

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Director, Global Regulatory

Pfizer
New York, NY 10007

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