Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $189.632 - $256.561 / Jahr

⏰ Vollzeit

🟠 Senior

🚔 Compliance

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Amgen

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10.000+ Mitarbeiter

Gegründet 1980

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen ist ein weltweit führendes Unternehmen in der Biotechnologie, das sich auf die Entwicklung und Vermarktung innovativer Arzneimittel aus lebenden Zellen konzentriert. Das Unternehmen hat zum Ziel, schwere Krankheiten zu behandeln, wobei oft Krankheiten im Fokus stehen, für die es nur begrenzte therapeutische Möglichkeiten gibt. Amgen legt großen Wert auf wissenschaftliche Innovation und ist der ethischen Forschung, der Patientensicherheit und der ökologischen Nachhaltigkeit verpflichtet. Es ist aktiv in klinischen Studien engagiert und bekannt für seine Beiträge in den Bereichen Krebsbehandlung und Adipositas-Management unter anderem.

Beschreibung

• The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions. • The GRL is accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. • Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes. • Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations. • Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment and regulatory scenario planning. • Advise on key clinical development elements relevant to obesity programs. • Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams. • Oversee execution of major global regulatory submissions, including clinical trial applications and marketing applications. • Lead strategy development and preparation for key Health Authority interactions related to metabolic disorders. • Build, mentor, and support high-performing global regulatory teams.

🎯 Anforderungen

• Doctorate degree and 4 years of regulatory experience OR Master’s degree and 7 years of regulatory experience OR Bachelor’s degree and 9 years of regulatory experience • 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas. • Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints. • Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies. • Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues. • Proven ability to translate metabolic science into clear regulatory strategy and decision-making frameworks. • Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high-stakes situations. • Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus.

🏖️ Vorteile

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.