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Manager, US Regulatory Strategist


New York, NY
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Job Details

**The purpose of this role 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.

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

+ Direct liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements, and commitment closures.

+ Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.

+ Develop and implement regulatory strategies to support/maintain registrations. Maintain product licenses across all product platforms.

+ Understand regulatory environment and communicate priorities to global/regional stakeholders

+ Deliver project regulatory strategy, risk assessment, and PRS for assigned projects/products

**The major duties and responsibilities will include, but are not limited to:**

+ Accountable for ensuring or contributing to Global Regulatory Strategies and implementation plans (including core labels, risk registers) developed for assigned projects.

+ Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, and minimize resource demands while maximizing overall project delivery time and probability of success and facilitating post filing activities.

+ Partners with project teams and other customer groups (e.g., Brand Teams) to ensure required regulatory contributions (line plans, IND, NDA) meet business needs and are provided to the project teams, to agreed time, cost and quality standards.

+ Ensures regulatory plans are monitored, progress/variance communicated to Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.

+ Ensures 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.

+ Engages in appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.

+ Ensures business compliance and implementation of and adherence to Regulatory standards.

+ Develops and maintains constructive working relationship with FDA contacts.


+ B.S. Scientific Degree required. An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be an advantage but is not essential.

+ 2-5 years of regulatory experience required

+ Proven examples of delivery across a prouct's lifecycle with demonstrable contribution in US Regulatory

+ Regulatory experience including knowledge of NDA/IND, 505(b) (2) submission processes.

+ Experience managing multiple products simultaneously and different stages of the product lifecycle.

+ Experience in successfully communicating with US FDA, including leading and participating in such interactions.

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

+ Strong written and verbal communication skills

**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.

Last day to apply: Monday, January 8, 2018

Location Information: This position can be based at any US Pfizer site.

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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