Senior Manager, Regulatory Affairs

Job description

Accountabilities: Lead and coordinate regulatory activities for assigned development projects across clinical, non-clinical, and CMC functions, ensuring milestones and submissions are delivered accurately and on schedule. Develop and implement regulatory strategies and tactics designed to support the earliest possible approvals and clearances for assigned products. Manage the preparation, writing, assembly, review, and submission of regulatory dossiers for investigational and registered products in the United States and applicable international markets. Lead preparation and submission of INDs, amendments, BLAs/NDAs, supplements, annual reports, safety reports, and other regulatory documentation. Prepare and manage regulatory meeting requests and briefing packages, ensuring materials are complete, consistent, and aligned with regulatory strategy. Represent Regulatory Affairs on cross-functional project teams, providing regulatory expertise, guidance, and recommendations to support development and business objectives. Maintain regulatory submissions and archives in accordance with applicable requirements and internal procedures. Monitor regulatory developments and communicate significant changes, risks, and opportunities to relevant stakeholders and management. Work effectively with external regulatory consultants, CROs, and other partners when required. Support continuous improvement of regulatory processes while maintaining a strong focus on compliance, quality, and timely execution. Requirements Bachelor’s degree in a relevant discipline, with 7+ years of related regulatory affairs experience; equivalent professional experience may be considered. Demonstrated experience preparing and managing IND submissions, including amendments and supporting documentation; NDA experience is strongly preferred. Strong knowledge of CTD/eCTD structures and regulatory submission processes, including experience publishing documents using Adobe Acrobat Professional or comparable tools. Working knowledge of FDA regulations and guidance, as well as applicable ICH requirements; familiarity with regulatory frameworks in other regions is a plus. Solid understanding of GMP, GLP, and GCP requirements and the pharmaceutical product development lifecycle. Strong ability to coordinate complex, cross-functional regulatory projects involving multiple technical disciplines and stakeholders. Excellent written and verbal communication skills, with the ability to translate complex regulatory matters into clear recommendations and action plans. Superior planning, organization, prioritization, and attention-to-detail skills, with the ability to manage multiple deadlines and responsibilities with minimal supervision. Self-motivated and proactive, with sound judgment and the ability to operate effectively in an entrepreneurial, fast-paced environment. Demonstrated analytical thinking, initiative, adaptability, continuous-learning mindset, and results orientation. Collaborative leadership style with the ability to build productive relationships, provide clear feedback, embrace change, and communicate effectively across teams. The role does not include direct supervisory responsibilities. Benefits Annual base salary: $139,800–$184,800, with final compensation determined based on factors such as experience, skills, education, certifications, and work location. Eligibility for an annual bonus plan for non-commercial roles. Eligibility for discretionary equity awards and participation in an Employee Stock Purchase Plan. Comprehensive medical, dental, and vision insurance. 401(k) retirement plan. FSA/HSA options. Life insurance coverage. Paid time off and wellness programs. Remote work arrangement within the United States. Opportunity to work in a collaborative, international environment focused on advancing innovative oncology treatments and improving patient access. Commitment to an inclusive workplace where collaboration, continuous learning, bold thinking, and patient focus are valued. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Regulatory Affairs based in United States. This is a strategic regulatory leadership role supporting the development and registration of innovative oncology products across the United States and international markets. You will manage complex regulatory projects spanning clinical, non-clinical, and CMC activities. The role offers the opportunity to shape submission strategies and accelerate regulatory pathways from development through approval. You will work closely with cross-functional teams and provide expert regulatory guidance throughout the product lifecycle. The position combines hands-on submission management, strategic planning, regulatory intelligence, and technical writing. Success requires strong judgment, organization, communication, and the ability to operate independently in a fast-paced environment. This is an impactful opportunity to contribute to bringing potentially life-changing medicines to patients more efficiently.