Associate Director, Global Regulatory Project Management

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $146.7k - $196.7k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 1%

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

• Translate, implement, and advise on global regulatory strategies across drug development programs • Provide strategic regulatory oversight for global product development, submissions, and lifecycle management • Lead and manage 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 activities and ensure delivery on time • Organize and facilitate global cross-functional meetings • Identify risks, propose solutions, and manage critical regulatory submission issues • Oversee preparation and submission of investigational and marketing registration documentation • Build partnerships with senior stakeholders and clinical, medical, safety, CMC, and commercial teams • Liaise and negotiate with cross-functional teams to expedite submissions and resolve regulatory issues • Mentor and guide junior staff • Champion process optimization and contribute to regulatory processes and policies • Potentially supervise Regulatory Project Management staff and oversee global cross-functional project teams • Occasional travel to support global project teams, regulatory meetings, and industry conferences

🎯 Requirements

• Bachelor’s degree in Science or related discipline • Minimum 8+ 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 • Skilled in conflict resolution and negotiation • Proficiency with Smartsheets, MS Project, Power BI, and Microsoft Office • Ability to learn and adapt to new software and digital collaboration tools • Experience with electronic document management systems and regulatory submission platforms preferred • PMP or similar certification preferred • Occasional international and domestic travel may be required

🏖️ Benefits

• Annual bonus plan eligibility for non-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