BeiGene · 11 hours ago
Executive Director, Regulatory Affairs, Solid Tumor Lead
United States
Full-time
Remote
Director/Executive
$212K/yr - $292K/yr
14+ years exp
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Responsibilities
Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge both strategically and operationally to support the development of the solid tumor portfolio and projects, and regulatory issues to support corporate goals.
Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory strategic development plans and risk assessments, critical issue management and advice on FDA interactions.
Oversees the preparation of NA regulatory documentation and ensures timelines are met, including the review of NA submission documents in support of clinical trials and marketing applications, and their amendments to support investigational and marketing registration packages within the US and Canada.
Supports the NA solid tumor regional team to negotiate with the US FDA 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 the US regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of these regulations.
Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.
Trains, develops, and manages an effective regulatory team via direct and 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 in collaboration with the NA region, taking leadership for the regulatory contribution especially when more than one region is impacted.
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
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Required
Bachelor’s degree in a science related curriculum required.
BA/BS Degree with 14 plus years of experience in the biotechnical or pharmaceutical industry, and a minimum of 12 years’ experience in a Regulatory capacity with a broad background.
Thorough understanding of drug development process and the pharmaceutical industry including regulatory requirements and policy trends and able to identify and proactively respond to emerging regulatory trends anticipating future challenges and opportunities in strategy, able to identify scientific and/or clinical advances that impact drug development and regulations.
Integrates market needs and prioritization into strategy development.
Is considered expert in US FDA strategy development and execution with successful track record including regulatory experience with INDs, NDAs/BLAs, lifecycle management, interactions with US FDA, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record.
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 major strategic challenges (e.g., new competition, shifting market environment) and opportunities to expedite development and regulatory processes, 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.
Strong people management skills, able to encourage, support and empower a team of NA strategists.
Excellent interpersonal, oral and written communication skills.
Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to 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 innovative solutions.
Proven ability to build trust and respect within the organization.
Ability to prioritize and handle multiple projects simultaneously.
Interacts with BeiGene employees and senior management.
Interacts with external business partners and Regulatory Agencies.
Preferred
Advanced degree preferred.
Preferred candidates will have extensive experience working with the US FDA in the oncology therapeutic area.
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeiGene
BeiGene is a global oncology company.
10,001+ employees
H1B Sponsorship
BeiGene 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
2023 (28)
2022 (36)
2021 (34)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$6.79BKey Investors
Hillhouse InvestmentAmgen
2020-07-12Post Ipo Equity· $2.08B
2019-10-31Post Ipo Equity· $2.7B
2018-08-02Post Ipo Secondary· $903M
Leadership Team
John V. Oyler
CEO & Founder
Aaron Rosenberg
Chief Financial Officer
Recent News
2024-11-27
Company data provided by crunchbase
