Director, Global Regulatory Project Management

🕒 5 days ago

🇺🇸 United States – Remote

💵 $176k - $236k / year

⏰ Full Time

🔴 Lead

👷‍♀️ Project Manager

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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

• Support, translate, and implement global regulatory strategies across drug development programs • Advise Global and Regional Regulatory Leads on product development, submissions, and lifecycle management • Lead complex IND/CTA, NDA/BLA/MAA regulatory submissions across multiple regions • Translate regulatory strategy into actionable project plans and drive operational execution • Coordinate cross-functional meetings and track submission activities • Identify risks, propose solutions, and manage critical submission issues • Oversee preparation and submission of investigational and marketing registration documentation • Build partnerships with clinical, medical, safety, CMC, and commercial teams • Liaise and negotiate with cross-functional teams and regulatory authorities • Mentor and develop junior and mid-level staff • Champion regulatory project-management process improvements • Develop and implement regulatory processes and policies

🎯 Requirements

• Bachelor’s degree in Science or related discipline • Minimum 10+ years of experience in regulatory project management and regulatory submissions • Experience with both small molecules and biologics • Significant global exposure • Demonstrated strategic regulatory leadership and successful submissions in multiple regions • Experience leading cross-functional and cross-regional teams • Strong business acumen and strategic thinking • Ability to integrate multiple sources of data for decision-making • Excellent verbal and written communication skills • Ability to understand and translate complex regulatory issues • Conflict resolution and negotiation skills • Proficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BI • Advanced skills in Microsoft Office suite (Word, Excel, PowerPoint, Outlook) • Ability to learn and adapt to new software platforms and digital collaboration tools • Experience with electronic document management systems and regulatory submission platforms is preferred • Advanced degree preferred • PMP or similar certification preferred

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Occasional international and domestic travel may be required

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