Director, Regulatory CMC - Cell Therapy
Scorpion Therapeutics
GRS-CMC Director (Cell Therapy) Responsibilities Develop and communicate strategic regulatory direction based on global guidelines and experience. Prepare/oversee CMC submissions; ensure thoroughness, completeness, and timeliness. Review CMC Leads’ submissions for clarity (strategic and technical). Use electronic systems for dossier creation, review, and tracking. Manage, coach, and support growth of direct reports; participate in leadership/department meetings. Anticipate and communicate regulatory paradigm shifts. Represent GRS-CMC in product fact-finding/R&D forums and cross-functional teams; support due diligence/in-licensing. Represent BMS at Health Authority meetings; act as a credible spokesperson. Manage relationships with diverse teams; support CMC policies/procedures. Ensure regulatory compliance by monitoring/verifying timely and accurate regulatory data entry. Qualifications Minimum BA/BS degree. 10+ years pharmaceutical/related experience (prefer multidisciplinary) and 8+ years regulatory CMC experience. Required/Preferred Skills & Competencies Knowledge of CMC regulatory requirements for advanced therapies/cell therapy (development and post-approval as applicable). Deep understanding of advanced/bio/ cell therapy processes and analytical methods. Ability to lead multifunctional teams, prioritize multiple projects, and work independently. Proven experience influencing/negotiating and resolving issues; communicate strategy/risks to senior leadership and governing bodies. Strong grasp of global regulatory laws/policies/guidelines; ability to break down complex science for regulatory audiences. Proficient with electronic systems; travel up to 5%. Benefits (if applicable) Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability/life insurance. Paid time off (flexible time off/annual vacation per employee category). #J-18808-Ljbffr Scorpion Therapeutics
$199.95k - $242.3k
## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ - USFind out how well you match with this job**Working with Us** Challenging. Meaningful... ...a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and...SuggestedHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Scorpion Therapeutics in Madison, New Jersey is seeking a GRS-CMC Director to oversee regulatory submissions and lead multifunctional teams. The... ...8+ years in regulatory CMC. A strong understanding of cell therapy processes is essential, along with the ability to lead...Suggested
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