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DSRD Regulatory Science and Operations Lead

Pfizer


Location:
San Diego, CA
Date:
09/19/2017
2017-09-192017-10-18
Job Code:
1613231
Pfizer
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Job Details

Job Title DSRD Regulatory Science and Operations Lead

JobID 1613231

Location: San Diego, CA

Description The position is located in the nonclinical toxicology division (i.e. DSRD) of Pfizer; specifically, within the Regulatory Strategy and Compliance (RSC) group which is responsible for providing nonclinical toxicology support for submissions to regulatory agencies worldwide and for influencing the external regulatory environment. Reporting to the DSRD Global Regulatory Submissions Lead, the DSRD Regulatory Science and Operations Lead will provide a senior level of strategic, operational and technical scientific support to RSC. In particular Regulatory Science and Operations Lead will:



- Provide scientific leadership, subject matter expertise in nonclinical safety sciences, and coordinate DSRD responses to new regulatory guidelines/regulations (worldwide), working closely with DSRD RSLs, SMEs and WSR.

- Forge strong relations with WSR External Affairs/Intelligence groups

- Survey the nonclinical regulatory environment for issues that may impact Pfizer or the industry

- Lead strategic improvement initiatives utilizing Project and Change Management tools and methods to drive decisions that will increase the performance of RSC

- Ensure RSC resources are optimized in support of WRD and DSRD portfolio priorities

- Develop, collect, interpret RSC metrics and report KPIs to the RSC-LT and DSRD ET

- Responsible for external vendor management within RSC

- Perform duties associated with the Regulatory Submission Scientist as needed



**ROLE RESPONSIBILITIES**



+ Perform all submission responsibilities in compliance with regulatory standards.

+ Apply advanced knowledge of international regulatory standards and expectations to establish and promote best practices in nonclinical regulatory science

+ Responsible for proactively surveying nonclinical regulatory environment (regulations/guidance)/ literature for issues that may impact Pfizer or the industry

+ Lead DSRD response to draft regulatory guidance documents, industry consortia white papers, and other external organizations.

+ Forge strong relations with WSR Regulatory Intelligence group in Pfizer to monitor developments in guidances and best practices

+ Responsible for surfacing operational improvement ideas that impact RSC systems and business processes (eg Portfolio Tracking Sheet, development implementation of a Regulatory Query Database, etc); this will involve analyzing and interpreting performance and trends in submission outcomes, and adapting processes to increase success rates. Make implementation plan recommendations to the RSC Leadership Team.

+ Ensure efficient utilization of RSC submission resources in support of WRD and DSRD portfolio priorities

+ Evaluate RSC's workload versus capacity; make recommendations to the RSC Leadership Team that will align organizational resources and process improvements to meet the needs of the portfolio

+ Responsible for managing external vendor relations/contracts for RSC (throughout the life of a contract)

+ Responsible for developing, collecting and interpreting RSC metrics (including KPIs)

+ Scientific knowledge of drug development, and significant expertise of regulatory toxicology or related safety disciplines

+ Contribute to the quality of nonclinical toxicology components of regulatory submission dossiers, query responses and other documents supporting interactions with regulatory agencies by performing duties associated with the Regulatory Submission Scientist role.



**QUALIFICATIONS**



+ Graduate degree in toxicology or related scientific area

+ 7 years+ experience in drug development or a business area closely related to the pharmaceutical industry

+ Project Management Professional (PMP) qualification desirable

+ Experience in leading and managing complex pharmaceutical or related life science projects

+ Experience in leading and influencing multi-functional teams



Other information:



+ Location- La Jolla

+ Frequent cross-site travel.

+ Relocation eligible

+ Eligible for Employee Referral

+ Grade 13



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.



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.

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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



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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