Job#: 2035146
Job Description:
Head of Regulatory Affairs – Immunology/Oncology 2035146Location: Greater Boston, MA (Hybrid)
Therapeutic Area: Immuno-Oncology/Autoimmune
Job Overview: This role is for a knowledgeable and experienced Regulatory Affairs professional to lead the development of comprehensive regulatory strategies to support clinical stage activities, responsible for developing efficient strategies and coordinating medical activities for clinical development programs in cancer immunotherapy and autoimmune diseases.
Primary Job Responsibilities:
- Designs and implements regulatory strategies for clinical trial applications
- Oversees regulatory filings and serves as corporate liaison with regulatory agencies
- Provides regulatory guidance for project teams, department compliance, and to assure compliance
- BS required, PhD(preferred) in biomedical sciences or related fields with 10 years of experience in biopharmaceutical industry and 7 years in regulatory strategy
- Expertise in regulatory submissions (IND and BLA), writing scientific and technical documents, non-clinical and clinical development, and regulatory guidelines of multiple agencies including international
- Demonstrated track record of regulatory meetings, submissions, and approvals
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.
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 [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
