Director of Regulatory Affairs in Cambridge, MA at APEX Systems

Date Posted: 8/13/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/13/2019

Job Description

Job #:  978595
Director of Regulatory Affairs, 978595
Job Scope & Purpose:
Our Cambridge based client is seeking a Director of Regulatory Affairs to join their growing team. This position will be responsible for developing and implementing global regulatory strategies while effectively managing internal and external relationships to drive performance. If you have a demonstrated track record of success within Regulatory Affairs for a biotech/pharmaceutical company, continue reading and consider applying today.
Primary Job Requirements:
  • Ph.D., MD, PharmD or MS with commensurate experience
  • 7+ years of global regulatory experience in a strategy function, from early to full development
  • Understanding of global and US policy, laws, regulatory and guidance/guidelines
  • Demonstrated high-level competency in drug development processes and understanding of scientific content and complexities; especially in rare and orphan disease development
  • Direct experience in leading the development of global and US regulatory strategies and leading teams through HA interactions and to drug/biologics approvals
  • Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals

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.
 
achan@stratacuity.com
 
Code: RegQA
 
 
 
 
 
 
 
 
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.