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Global Regulatory Strategy Regional Lead


Collegeville, PA
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Job Details

Job Title Global Regulatory Strategy Regional Lead

JobID 1618159

Location: Collegeville, PA

Description + The purpose of this role is to:

+ Represent a particular region for regulatory affairs (US, EU or EM) on the GRT, labelling, project teams.

+ Provide regional strategic expertise as a member of the Global Regulatory Team (GRT)

+ Lead and implement regional regulatory strategies that are in alignment with the global regulatory strategy as agreed with the GRL, GRT and other key stakeholders for assigned projects/products,in line with the VRU and VBU objectives.

+ Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region

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

+ Role can be combined with other Regulatory Role(s) (i.e. Global Regulatory Lead).

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

**Primary Responsibilities**

+ Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.

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

+ Partners with project teams and other customer groups (e.g. RU/BU, Regional Commercial Teams) to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc) meet business needs and are provided to the project teams, to agreed time and quality standards.

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

+ Ensures that an aligned regional regulatory position is agreed with the GRT/GRL and that these regulatory positions supporting the regional business are championed and communicated.

+ Engages in appropriate activities in order to influence the regional regulatory environment through WRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.

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

+ Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.


+ Scientific Degree. A higher degree may be an advantage but is not essential.

+ Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country. Minimum 5 years experience required, 10 is preferred

+ Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry-government collaborations, can be considered

Experience in communicating with FDA or major EU regulatory agency(ies) for US and EU regulatory strategists respectively, as well as participating in/leading such interactions, is preferred.

**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:**

+ **Last Date to Apply for Job: 10/31/17**

+ **This job is Pfizer Exempt US Grade: 17** Additional Location Information: Pearl River, NJ and New York City

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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