BeOne Medicines ยท 1 day ago
Director, Global Regulatory Lead
United States
Full-time
Remote
Lead/Staff, Director/Executive
$176K/yr - $236K/yr
5+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, and they are seeking a Director, Global Regulatory Lead. The role involves developing and implementing global regulatory strategies to secure market access for products and providing leadership on regulatory aspects throughout the development and lifecycle of the product.
Pharmaceuticals
Responsibilities
Provides high level global strategic and operational regulatory direction and leadership on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in global markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions
Uses extensive knowledge of global regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals
Supports the preparation and submission of global regulatory documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met including the review global submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages throughout the world
Supports regional team to negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes
Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation
Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business
Manages and leads an effective global regulatory project team via indirect reporting structure
Builds partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
Manages critical issues, taking leadership for the regulatory contribution
Responsible for assisting with the development and implementation of regulatory processes
Mentors regulatory professionals and helps create a goal oriented culture
Qualification
Required
BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry
5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge and substantial working experience
Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities
Leading cross-functional regulatory teams
Developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
Strong business acumen and ability to make sound decisions that contribute positively to the business
Strong strategic skills including creativity and effectiveness in identifying and addressing strategic challenges
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Excellent interpersonal, oral and written communication skills
Skilled in conflict resolution/negotiation
Strong negotiating skills and ability to think creatively and develop innovative solutions
Proven ability to build trust and respect within the organization
Ability to prioritize and handle multiple projects simultaneously
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Ability to work on a computer for extended periods of time
Must be willing to travel approximately 10-20%
Preferred
Experience working as a lead in Regulatory Affairs across two or more major geographic areas
Prior experience with both small molecules and biologics
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase