Director, Regulatory Affairs
Director, Regulatory Affairs 1333730
Location: Waltham, MA (Remote)
Science/ Focus: Monoclonal Antibodies
Therapeutic Area: Viral infections
Job Overview: This individual will be responsible for the management and execution of regulatory activities across US and Global programs.
Responsibilities:
- Perform regulatory assessment of GXP data and determine impact on product development.
- Manage timelines and project management to ensure on-time regulatory submissions.
- Assist with the planning, scientific writing and perform critical reviews of regulatory documents (pre-INDs, INDs, BLAs, MAAs, annual reports, DSUR, amendments, etc.)
- Collaborate cross-functional and provide regulatory advice and strategy for clinical and nonclinical development to support, IND, CTA and marketing applications.
- Participate, in planning, organizing and managing the content of meetings with regulatory agencies.
Qualifications:
- BS Degree: Advanced Degree preferred
- 8+ years of pharmaceutical or biotechnology industry experience
- Experience with submission of INDs and BLAs
- Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements
- Biologics experience 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.
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 employeeservices@apexsystems.com or 844-463-6178.