- Designs and implements regulatory strategies for obtaining and maintaining clinical trial applications.
- Provides regulatory guidance and input to project teams, ensuring compliance with applicable regulations.
- Oversees the creation and submission of all regulatory filings within their scope of responsibility.
- Serves as the corporate liaison with regulatory agencies, building positive relationships and maintaining a positive company image.
- Bachelors Degree in Life Science required, PhD in biomedical sciences or related fields preferred. Regulatory Affairs Certification (RAC) a plus.
- Minimum 10 years of experience in the biopharmaceutical industry, with at least 5 years of direct experience in a regulatory strategy role.
- Oncology and Immuno-oncology experience a PLUS.
- Expertise in regulatory submission structure and content, including IND, CTA, MAA, NDA, BLA, and extensive knowledge of regulatory guidelines of FDA, ICH, EMA, EU NCAs, MHRA, and other international regulatory agencies.
- Must have experience supporting clinical development teams specifically in autoimmune disease
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Sr. Director, Clinical Regulatory Affairs, Auto-Immune - Watertown, United States - Stratacuity
Description
Location: Waltham, MA (Hybrid)
Therapeutic Area: Auto-Immune
Job Overview: This role involves developing regulatory strategies, leading interactions with regulatory authorities, overseeing regulatory submissions, serving as the global regulatory lead, collaborating with the development team, and effectively managing external vendors.
Primary Job Responsibilities:
Primary Job Requirements:
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.
