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Exec Dir Regulatory Gene & Cell based Therapeutics


Cambridge, MA
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Job Details

Job Title Exec Dir Regulatory Gene & Cell based Therapeutics

JobID 1044328-1852

Location: Cambridge, MA

Description *About Pfizer*

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

*Role Description*

The WSR Executive Director for GTx/CTx is an experienced leader with global reach, relationships & responsibilities who provides regulatory leadership, guidance & support for emerging & innovative gene & cell-based therapeutic products. The WSR Executive Director is accountable for cultivating & maintaining a sustainable, integrated & aligned regulatory network internally and externally to Pfizer and leveraging matrixed connections across lines to develop robust regulatory strategies for the evolving GTx & CTx product portfolio. The individual also provides regulatory expertise in the evaluation of GTx & CTx business development opportunities. This role is predicated on well-grounded technical/scientific expertise in advanced therapeutics, global regulatory knowledge & experience, balanced judgment, exemplary collaboration & business acumen. The WSR ED for GTX & CTx maintains high standards for quality of global regulatory submissions, strategies & risk assessments. The WSR ED for GTX & CTx is responsible for cultivating sustainable & effective relationships with local & global internal partners, in WRD & PIH, leveraging technical & regulatory experience & innovations, exercising & maintaining engagements/relationships with regulatory authorities to improve Pfizer's regulatory success, leading and contributing to external groups to positively influence innovation in advanced therapeutics, & contributing to a cohesive, flexible, efficient, innovative & adaptive organization.


*Foster & actively develop a WSR expertise in development & regulatory prosecution of GTx & CTx therapeutic products*Ensure all regulatory activities are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.*Cultivate & manage relationships with partner leaders in WSR particularly with GPD, RD RU, WRD, PIH, GCMC, PharmSci*Provide guidance & direction for specific GTx & CTx projects, initiatives & policies*Represent Pfizer externally on GTx & CTx topics and influences regulatory advancement at global scientific forums*Communicate regularly with key stakeholders to ensure alignment. *Provide guidance & direction to mitigate & support regulatory risk & integrate CMC strategy and clinical product strategies.*Demonstrate well-grounded judgment & crisp decision-making, i.e, regulatory strategy development, regulatory submission quality, & policy approvals, etc.


*Advanced Scientific Degree (M.D. or Ph.D.) *Demonstrated experience in the Pharmaceutical industry; in development of GTx & CTx programs *In depth and relevant Global regulatory experience in advanced therapeutics*Significant and / or transferable experience with accelerated development programs in rare disease through prior in-depth regulatory experience / leadership roles*Demonstrated strategic thinking and ability to integrate strategies into actionable plans.*Proven ability to function autonomously at a senior level in a highly matrixed organization.*Demonstrated experience and knowledge to assess technical, scientific & regulatory merits of GTx & CTx strategies, commitments and data.*Unequivocal understanding of global regulatory requirements, local regulatory expectations, criteria for submission & approval.*Experience negotiating with regulatory authorities.*High level of business acumen that includes innovative advancements in early and full clinical development and associatedCMC development with GTx & CTx therapeutic products.*Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.*Mature demeanor to effectively collaborate & guide under accelerated timelines & volatile business pressure - not inclined toward reactionary or hasty judgment.PHYSICAL/MENTAL REQUIREMENTS *The WSR Executive Director for GTx & CTx works in an office setting where physical requirements are consistent with typical office functions & activities. This position must be affilitated with a Pfizer facility.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS *A WSR Executive Director for GTx & CTx has global reach & is expected to travel domestically & internationally as required. *The external global regulatory environment is dynamic & may demand work outside of conventional working hours and on weekends from time to time.

*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.

*Exec Dir Regulatory Gene & Cell based Therapeutics*
*Cambridge, Massachusetts*

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