VP/Sr. Director, Regulatory Affairs - Oncology in Boston, MA at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

Job Description

Job #:  1009483
Senior Director, Regulatory Affairs Oncology 1009483
Job Scope & Purpose:
Our long-term, established oncology-focused client is seeking an experienced drug Regulatory Affairs professional to join their collaborative team environment. Sr. Director, Regulatory will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMA, and other key market Health Authorities as applicable and ensure these activities are consistent with the overall global strategy and activities. An integral part of this role is to foster strong relationships and advocacy with FDA as well as other international regulatory authorities, as required. This leadership role will entail oversight of vendors for the preparation of the regulatory submissions and interaction with key members of the Project Teams and agencies/health authorities. This individual will function as a key team member of the team, influencing the development strategy and to defend the regulatory position with health authorities.
Primary Job Responsibilities:
  • Develop, lead and implement global regulatory strategy
  • Act as primary contact with regulatory agencies
  • Lead the preparation of submissions, such as INDs, briefing packages, and fast track applications
  • Lead the development of clinical development plans with cross-functional teams
  • In collaboration with functional team members, assist in the design of clinical study plans, development of statistical and interim analysis plans, and interpretation of clinical study data
  • Manage RA CMC activities to support global clinical trials investigational products, developing strategies for appropriate filings and responses to health authority queries.
  • Provide and oversee strategic direction and guidance to CMC, Quality Assurance, and Commercial on both global and key strategic business initiatives
  • Create new processes to support the evolution of the company

Primary Job Requirements:
  • Bachelor’s degree in a scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10 years in Regulatory Affairs.
  • Minimum of 7 years of regulatory experience within the drug development and approval process in INDs, CTAs and marketing applications
  • 5 years or more of recent therapeutic experience in Oncology; Experience in multiple phases of oncology development
  • Successful track record of FDA interactions
  • Experience working with innovator products and designing and executing creative development strategies are highly desirable. In-depth understanding of the drug development process for all phases of pharmaceutical development
  • Must have a solid understanding of FDA regulations and ICH guidance, as well as a comprehensive knowledge of the drug development process.
  • Able to handle multiple projects and exercise good judgment in prioritizing tasks
  • Demonstrate the ability to work independently and within a group setting, and to interact effectively with various functional groups.
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
  • High level of attention to detail, and be proficient with Microsoft Office applications, Adobe and document management templates.
  • Global experience required
  • Domestic and occasional international travel may be necessary.
  • Experience with companion diagnostic development is preferred

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.