Vice President, Regulatory Affairs and Quality Assurance
Vice President, Regulatory Affairs & Quality Assurance 1333900
Location: Waltham, MA (Remote)
Science/ Focus: Monoclonal Antibodies
Therapeutic Area(s): Viral infections
Job Overview: This individual will be responsible leading all regulatory and clinical quality assurance functions including regulatory strategy and leading interactions with global regulatory authorities.
Responsibilities:
- Provide strategic direction leadership for Regulatory Affairs, Clinical Quality and Medical Writing departments
- Direct and negotiate submissions (IND, CTA, BLA, MAA, etc.) and approvals with regulatory authorities.
- Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
- Oversee the design, analysis, and oversight of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures.
- Oversee the quality oversight of GCP, GVP and GLP activities (including SOP/policy development and maintenance, Vendor Management, internal and external audit functions, and clinical batch release program) to ensure patient safety and data integrity.
Qualifications:
- BS degree: Advanced degree preferred.
- 15+ years' experience in Regulatory Affairs and Quality Assurance with 10+ years leadership experience.
- Experience leading, designing, writing, and submitting regulatory filings for biologics, with significant BLA/MAA experience.
- Track record of successful negotiations and regulatory filings, specifically with the Center for Drug Evaluation and Research (CDER).
- Experience with COVID-19 therapeutics or vaccines is a must.
- Additional infectious disease experience a plus.
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.