Head of Regulatory Affairs - Immunology/Oncology

Head of Regulatory Affairs - Immunology/Oncology

Job#: 2035146

Job Description:

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

Primary Job Requirements:

• 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

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.

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.

EEO Employer

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