Manager, Global Regulatory Sciences 2075494Location: Cambridge, MA (Onsite)Science: Small MoleculeJob Overview: In this role, you will drive global regulatory strategy for mast cell disease programs, providing operational and strategic support to cross-functional teams while ensuring effective collaboration with external partners and regulatory authorities.Primary Job Responsibilities:Oversee key regulatory submissions to advance clinical development programs.Collaborate across cross-functional teams to align global regulatory strategies.Lead planning and preparation for critical health authority meetings.Provide strategic guidance to external vendors and consultants on regulatory requirements.Stay ahead of evolving regulatory guidelines, ensuring compliance and strategic adaptation.Primary Job Requirements:Bachelor's degree in a scientific discipline, advanced degree preferred.4+ years in drug development, with regulatory experience as a plus.Oncology/rare disease experience and IND filing expertise are valuable.Strong knowledge of US regulatory requirements, global experience a plus.Excellent communication and collaboration skills in a fast-paced environment.Organized and detail-oriented, managing multiple priorities effectively.Adaptable problem-solver, thriving in ambiguous situations.Proficient in Microsoft Word, Excel, PowerPoint, SmartSheet, and Adobe Acrobat. 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. 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 EmployerApex 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.