VP/Head Regulatory - Cell Therapy in Cambridge, MA at APEX Systems

Date Posted: 11/19/2019

Job Snapshot

Job Description

Job #:  982553
Vice President Regulatory Affairs, 982553
Job Scope & Purpose:
Our client’s mission is to develop and deliver transformative cell therapies for patients suffering from life-threatening virus-associated diseases for immunocompromised patients. They are currently planning and advancing mid- and late-stage clinical trials across our growing product pipeline and seek an accomplished VP-level Regulatory Affairs professional!
The VP Regulatory Affairs will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.
Primary Job Responsibilities:
  • Direct global clinical, non-clinical, and CMC regulatory strategies
  • Provide regulatory guidance throughout the research and development process
  • Identify and assess regulatory risks & define strategies to mitigate such risks
  • Prepare clear and effective regulatory submissions leveraging internal and external resources
  • Prepare and lead meetings with regulatory bodies to include but not limited to Pre-IND meetings, Type C meetings, EOP II meetings, pre-NDA meetings, and EU Scientific Advice
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess the impact on programs
  • Build and maintain excellent relationships with relevant regulatory agencies
  • Effectively manage contractors and corporate partners
  • Prepare and deliver effective presentations for external and internal audience
  • Able to articulate complex regulatory issues and support global development and commercialization of early and late state programs

Primary Job Requirements:
  • BA/BS/University degree required, Life/Health Sciences preferred
  • 10 years pharmaceutical/biotechnology industry experience with technical management experience
  • Quality and breadth of experience working across small molecule and biologics
  • Minimum of 8 years in Regulatory Affairs
  • International regulatory experience necessary
  • Direct experience in interfacing with relevant regulatory authorities
  • Foster effective, positive interactions with regulatory agencies, and corporate partners

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
jprice@stratacuity.com
Code: ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.