Senior Director, Regulatory Affairs, CMC

🕒 February 24

🇺🇸 United States – Remote

💵 $204.5k - $274.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 36%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Lead and develop the U.S. Biologics Regulatory CMC team • Provide strategic and operational leadership for global biologics Regulatory CMC strategies • Partner closely with global cross-functional stakeholders on CMC regulatory strategies • Establish and continuously improve Regulatory CMC standard operating procedures (SOPs) • Ensure appropriate Regulatory CMC assessment throughout the product lifecycle • Review and approve Regulatory CMC documentation within the RIM system • Represent the company in external forums and regulatory or scientific conferences

🎯 Requirements

• BA/BS Degree in scientific disciplines, MS/PhD preferred • 12+ years of relevant pharmaceutical or biopharmaceutical experience • At least 10 years of direct Regulatory CMC experience • Demonstrated track record of leading Health Authority interactions • Proven experience leading and developing teams of 10+ or more professionals • Advanced scientific training with hands-on expertise in at least one core pharmaceutical or biologics discipline • In-depth knowledge of ICH guidelines and global Regulatory CMC requirements • Extensive experience authoring, reviewing, and managing complex technical documentation

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness