Sr. Manager, Reg Affairs Oncology in Needham, MA at APEX Systems

Date Posted: 1/21/2020

Job Snapshot

Job Description

Job #:  1022846
Manager/Senior Manager, Regulatory Affairs, Oncology 1022846
Job Scope & Purpose:
Our long-term client, an oncology-focused biotech company committed to improving outcomes for patients with cancer, is seeking a Senior/Manager Regulatory Affairs. This individual would be responsible for assisting in the preparation and submission of INDs, IMPDs, NDAs, amendments, and other regulatory submissions as required in collaboration with appropriate leadership.
Primary Job Responsibilities:
  • This position requires familiarity with U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH guidelines, and familiarity with GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211). It also requires:
  • Assistance in preparation and submission management of INDs, IMPDs, NDAs, amendments and other regulatory submissions, as required. Coordinate with Clinical Research, Clinical Operations, Manufacturing, and other groups to assure timely and accurate preparation of regulatory submissions.
  • Assures accuracy and submission management of regulatory documentation according to established timeframes
  • Coordination with team members, in the preparation and submission management for Advertising and Promotion 2253/ Presubmission filings.
  • The ability to set up and maintain regulatory files and submission archives to assure proper storage and retrieval of regulatory documentation.
  • Preparation and maintenance of regulatory submission trackers and notification to and coordination with team members for upcoming submissions.
  • The ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events.
  • Assist in the preparation and review of timely draft and final reports, as appropriate.
  • Prepare and review standard operating procedures and policies, as appropriate
  • Develop and maintain a working knowledge in the specific areas related to GCP, GLP and GMP compliance including, but not limited to regulatory and ICH requirements.

Primary Job Requirements:
  • BA/BS in a scientific discipline
  • A minimum of 6 plus years of regulatory affairs experience in the biopharmaceutical area or equivalent is required.

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.