Director, Drug & Device Combo – Autoinjector/Inhalation Reg.-CMC

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🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $190.8k - $300.3k / year

⏰ Full Time

🔴 Lead

👔 Director

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs • Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities • Lead technical content writing and review in autoinjector (other device)/integral combination product documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems • Identify, communicate, and escalate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership • Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide

🎯 Requirements

• B.S. in a biological science, engineering, or a related field (advanced degree preferred) • 10 years relevant experience including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields for candidates with a Bachelor’s degree, or Master’s degree; minimum 5 years for candidates with a Ph.D. degree • subject matter expertise in combination product regulatory development and manufacturing • experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products • strong knowledge and understanding of design controls process

🏖️ Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • paid holidays • vacation • compassionate and sick days