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

Job not on LinkedIn

🕒 July 29

🏖️ 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

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

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 by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks • 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 • Conduct all activities with an unwavering focus on compliance, including staying current on all training.

🎯 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 • Demonstrated background in reviewing scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data • Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner • Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance)

🏖️ 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