BeOne Medicines · 1 week ago
Associate Director, Regulatory Affairs
United States
Full-time
Remote
Lead/Staff, Director/Executive
$147K/yr - $197K/yr
8+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking an Associate Director of Regulatory Affairs. The role involves developing and implementing regulatory strategies for North America, managing regulatory aspects of product development, and interfacing with regulatory agencies like the FDA and Health Canada.
Pharmaceuticals
Responsibilities
Provides high level regulatory strategic and operational direction for NA and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, regulatory strategic development plans and risk assessments, critical issue management and advice for the FDA and Health Canada interactions
Uses extensive knowledge of US, regulatory requirements and applies this knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals
Oversees the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada ensuring timelines are met in alignment with the global strategy as determined by the global regulatory leader
Reviews sections of the documents that will be utilized in the US and Canada in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
Liaises and negotiates with the FDA and Health Canada 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 assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation
Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business
Trains, develops, and manages an effective regional regulatory team both via direct and indirect reporting structure
Builds partnerships with senior 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
Recruits, develops, manages, and mentors regulatory professionals and helps create a goal-oriented culture
Qualification
Required
8+ years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years' experience in a Regulatory capacity with a broad background
Bachelor's degree required; advanced degree preferred
Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing 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
Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism
Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders
Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion
Strong negotiating skills and ability to think creatively and develop creative solutions
Proven ability to build trust and respect within the organization
Ability to prioritize and handle multiple projects simultaneously
Interacts with external business partners and Regulatory Agencies
Proven ability to build trust and respect within the organization
Ability to prioritize and handle multiple projects simultaneously
Experience with Microsoft Office suite
Veeva regulatory publishing
PowerPoint presentation authoring and presentation
Preferred
Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA, and 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