Senior Director Regulatory Affairs - Oncology in Waltham, MA at APEX Systems

Date Posted: 9/19/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Waltham, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    9/19/2019

Job Description

Job #:  990359
Director, Senior Director, Regulatory Affairs, 990359
Job Scope & Purpose:
Our esteemed client is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients and are seeking an experienced, high-level Regulatory Affairs professional will manage a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the development pipeline. This position will report to the Vice President of Regulatory Affairs and Quality.
Primary Job Responsibilities:
  • Working with the regulatory leads to develop regulatory strategies for multiple oncology development programs (from FIH through the post-marketing stage)
  • Address complex issues by providing solid regulatory solutions and guidance to the regulatory leads and, as needed, to the cross-functional teams and senior management
  • Monitor global regulatory changes that may impact asset development
  • Provide tactical support and operational expertise when “hands-on” support is needed
  • Counsel and advise Vice President of Regulatory Affairs & Quality on the status of Regulatory Affairs strategies and tactics, procedures and practices
  • Ensure compliance of regulatory strategies and submissions
  • Assess project plans and timelines; manage staff effectively to ensure all projects are appropriately prioritized and key goals are met on time
  • Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company
  • Manage staff performance and plays a key role in developing career growth opportunities for staff

Primary Job Requirements:
  • Ph.D. and 10+ years of work experience in pharmaceutical regulatory affairs, or
    • B.S/M.S. and 12+ years of work experience in pharmaceutical regulatory affairs
  • Advanced knowledge and experience in interpretation of regulations, guidelines, and precedents related to oncology drug development in the US and EU
  • Must have experience filing INDs and NDAs/BLAs

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: 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.