Director, Regulatory Affairs

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $176k - $236k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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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

• Develop, implement, and advise on North America regulatory strategies for development programs • Secure and maintain market access in North America in line with business objectives • Coordinate with the global regulatory leader and key internal stakeholders • Manage North American regulatory aspects of compounds through development, post-approval, and product lifecycle phases • Provide leadership and strategic regulatory oversight for designated projects • Interface with the FDA, Health Canada, and business partners regarding development, regulatory, and registration strategies • Provide line management, people development, and performance management • Support and lead development and implementation of department policies • Provide regulatory strategic and operational direction and project mentorship • Advise on clinical study requirements, marketing approval, strategic development plans, risk assessments, critical issues, and health authority interactions • Oversee preparation and submission of investigational and marketing registration documentation in the US and Canada • Review clinical trial and marketing application documents and amendments for US and Canadian requirements • Liaise and negotiate with the FDA and Health Canada on drug development, regulatory issues, approvals, and labeling changes • Monitor the global regulatory environment and assess impacts on business and product development programs • Facilitate regulatory policy development and standard interpretation of global regulations • Integrate functional expertise with business knowledge to solve problems and support business decisions • Train, develop, and manage a regional regulatory team through direct and indirect reporting structures • Build partnerships with senior stakeholders across functions • Lead regulatory contributions to critical issues • Assist with development and implementation of regulatory processes • Recruit, develop, manage, and mentor regulatory professionals • Create a goal-oriented culture

🎯 Requirements

• 10+ years of experience in the biotechnical or pharmaceutical industry • Minimum of 5 years’ experience in a Regulatory capacity with a broad background • Bachelor’s degree required • Experience working as a lead in Regulatory Affairs with the FDA preferred • Prior experience with both small molecules and biologics preferred • Thorough understanding of the drug development process, pharmaceutical industry, healthcare environment, regulatory requirements, and policy trends • Extensive experience with INDs/CTAs, NDAs/BLAs, lifecycle management, Health Authority interactions, regulatory team leadership, and regulatory strategy development • Proven track record of significant regulatory accomplishments • Strong business acumen and sound decision-making ability • Strong strategic skills, creativity, and ability to address strategic challenges • Ability to deliver goals within a cross-functional team/partnership environment • Excellent verbal and written communication skills • Ability to analyze, define, and communicate complex issues persuasively • Conflict resolution and negotiation skills • Strong negotiating skills and ability to develop creative solutions • Ability to build trust and respect within the organization • Ability to prioritize and handle multiple projects simultaneously • Experience with Microsoft Office suite • Experience with Veeva regulatory publishing • PowerPoint presentation authoring and presentation skills • Ability to interact with external business partners and regulatory agencies • Business travel availability of 10–20% as required

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Equal opportunity employer • Reasonable accommodation in the job application process

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