Senior Regulatory CMC Drug-Device Combination Product Lead

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $111k - $149k / year

⏰ Full Time

🟠 Senior

✅ Product Manager

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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