Senior Director, Regulatory Affairs Strategy

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Immunovant

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2018

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant ist ein Unternehmen, das sich darauf konzentriert, Behandlungen für Autoimmunerkrankungen mit einem patientenzentrierten Ansatz voranzutreiben. Mit der Vision, Menschen mit Autoimmunerkrankungen ein normales Leben zu ermöglichen, nutzt Immunovant seine Expertise in der Wissenschaft, um neue Therapien zu entwickeln und zu testen. Das Unternehmen legt Wert auf die komplexen und variablen Bedürfnisse in verschiedenen Stadien und Schweregraden von Krankheiten. Immunovant engagiert sich dafür, seine therapeutischen Bereiche und klinischen Studien voranzutreiben, während es gleichzeitig den Austausch mit Patienten, Pflegekräften und Investoren über laufende Studien und Unternehmensinitiativen fördert.

Beschreibung

• Lead the development and execution of innovative global regulatory strategies to expedite development, maximize probability of success, and mitigate regulatory risk across assigned programs. • Serve as a core regulatory strategist for complex and/or high-priority programs, with accountability for overall regulatory direction and outcomes. • Anticipate and proactively address regulatory challenges, translating external regulatory trends and guidance into actionable strategies. • Ensure alignment between program-level strategies and broader portfolio and corporate regulatory objectives. • Lead and/or play a prominent role in interactions with FDA and other global Health Authorities, including briefing document development, meeting preparation, negotiation strategy, and follow-up. • Provide strategic oversight and guidance on responses to regulatory questions, information requests, and post-meeting commitments. • Act as the primary regulatory partner on cross-functional development teams, influencing decision-making across R&D, Clinical, CMC, Quality, Pharmacovigilance, and Commercial functions as appropriate. • Clearly communicate regulatory risks, opportunities, and recommendations to senior management and key stakeholders. • Represent Regulatory Affairs Strategy on cross-functional governance forums and committees as needed. • Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory leaders. • Support performance management, talent assessment, and succession planning in partnership with Regulatory leadership. • Foster a culture of accountability, collaboration, and continuous learning within the Regulatory Affairs organization. • Oversee and contribute to the planning, preparation, and review of high-quality global regulatory submissions, including INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual reports, and briefing packages. • Ensure regulatory deliverables are strategically sound, internally aligned, and completed within established timelines. • Manage or oversee external consultants and vendors to ensure efficient execution and high-quality outcomes.

🎯 Anforderungen

• Bachelor’s degree in a scientific discipline required; advanced degree (Master’s or PhD) strongly preferred. • Minimum of 12–15+ years of regulatory experience in the biopharmaceutical industry, with demonstrated progression in scope and complexity. • Significant experience developing and executing global regulatory strategies for biologics across clinical development and, preferably, marketing applications. • Demonstrated leadership in Health Authority interactions, including FDA and major ex‑US agencies. • Strong understanding of global regulatory requirements, guidance, and processes (FDA, EMA, ICH, and other key regions). • Experience leading or contributing to INDs and BLAs; MAA experience preferred. • Proven ability to think strategically while remaining hands-on as needed. • Excellent written and verbal communication skills, with the ability to influence senior leaders and cross-functional partners. • Experience mentoring and developing regulatory talent in a matrixed, fast-paced environment. • Comfort operating with ambiguity and shifting priorities in a high-growth biotech setting.

🏖️ Vorteile

• full range of medical, dental, vision, 401k, and other benefits • unlimited paid time off • parental leave