Senior Regulatory CMC Drug-Device Combination Product Lead

🕒 vor 6 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $111.000 - $149.000 / Jahr

⏰ Vollzeit

🟠 Senior

✅ Produktmanager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Biogen

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5001 - 10000 Mitarbeiter

🏥 Gesundheitswesen

🏭 Fertigung

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Biogen ist ein Biotechnologieunternehmen, das sich der Entdeckung, Entwicklung und Bereitstellung innovativer Therapien für Menschen mit schweren neurologischen Erkrankungen widmet, einschließlich Alzheimer, Multiple Sklerose und spinale Muskelatrophie. Mit einem starken Fokus auf Forschung und Entwicklung treibt Biogen die Wissenschaft der Neurologie durch klinische Studien und strategische Partnerschaften voran und strebt dabei gleichzeitig nach Zugang und gesundheitlicher Chancengleichheit im Gesundheitswesen.

Beschreibung

• Represent the Regulatory CMC Device function on cross-functional teams and provide regulatory guidance for combination products and medical devices • Author and coordinate regulatory documentation and submissions while ensuring compliance with applicable regulations • Lead or assist in project assignments supporting business needs, including representing Regulatory CMC in cross-functional work streams • Develop and execute regulatory strategies for medical devices and combination products, including new registration submissions and post-approval applications • Communicate CMC regulatory strategies, risks, and overall plans to leadership and cross-functional teams • Author, review, and approve CMC submissions and responses to Health Authority questions in alignment with global regulatory strategies and timelines • Collaborate with cross-functional teams to prepare submissions and responses to Health Authority CMC questions • Monitor and communicate legislative and regulatory developments in relevant areas • Participate in regulatory intelligence activities and trade organization working groups • Develop and enhance regulatory processes and procedures • Build strong internal relationships and deliver effective presentations to internal audiences

🎯 Anforderungen

• Minimum of a bachelor’s degree (BS) • At least 5 years of regulatory experience, ideally in the medical device, pharmaceutical, or biotechnology industries • In-depth understanding of how regulatory functions within a business environment and interfaces with multiple functional areas • Experience in Medical Device and/or Combination Product Regulatory Affairs in a similar or junior role • Understanding of the application of cGMP for Medical Devices and Combination Products • Awareness of applicable legislation, regulations, guidance, and standards related to medical devices and combination products • Strong analytical abilities and attention to detail • Preferred: Degree in Life/Health Sciences or Engineering

🏖️ Vorteile

• Regular employees are eligible for short-term and long-term incentives, including cash bonus and equity incentive opportunities • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation • Additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation • Opportunities for learning, growth, and expanding skills