BeiGene · 9 hours ago
Executive Director, Global Regulatory Affairs Companion Diagnostics
United States
Full-time
Remote
Senior Level, Lead/Staff
$212K/yr - $292K/yr
12+ years exp
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Responsibilities
Lead the global regulatory strategy for companion diagnostics, ensuring alignment with therapeutic development and commercialization timelines.
Stay informed about evolving regulatory requirements, policies, and guidelines related to CDx, and proactively adapt strategies to meet new regulations.
Guide teams in the interpretation of regulatory requirements, providing strategic insights to integrate CDx with the company’s therapeutic programs.
Coordinate all regulatory submissions for companion diagnostics, including Investigational Device Exemptions (IDE), Premarket Approval (PMA) applications, and other required filings with the FDA, EMA, and other global health authorities.
Oversee the preparation and submission of regulatory documents and responses, ensuring timely and accurate submissions that meet global regulatory requirements.
Act as the primary point of contact for regulatory bodies, managing relationships and communications to facilitate efficient reviews and approvals.
Work closely with Clinical Biomarker Science and CDx Development, Clinical Development, Research & Development, Commercial, and Legal teams to integrate regulatory requirements into the overall CDx development process.
Collaborate with external diagnostic and pharmaceutical partners to align on regulatory strategies and ensure consistent regulatory approaches across programs.
Support the integration of CDx into clinical trials, ensuring all regulatory aspects are addressed to enable timely initiation and execution.
Ensure all companion diagnostic products comply with applicable global regulatory requirements and standards (e.g., FDA, EMA, ISO, etc.).
Identify regulatory risks and provide mitigation strategies throughout the CDx product lifecycle.
Lead efforts to audit and maintain compliance with internal and external regulations, including leading responses to regulatory inspections and audits related to CDx.
Develop and maintain productive relationships with regulatory agencies, representing the company in meetings, consultations, and negotiations.
Provide regulatory expertise to cross-functional teams, advising on regulatory interactions, inspections, and compliance-related matters for companion diagnostics.
Lead, mentor, and develop a team of regulatory professionals focused on companion diagnostics, fostering a culture of regulatory excellence.
Ensure continuous development of the team’s regulatory expertise and professional growth in line with evolving industry standards.
Qualification
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Required
Bachelor’s, Master’s, or PhD in Life Sciences, Regulatory Affairs, or a related field.
12+ years of regulatory experience in the life sciences industry, with at least 5 years focused on companion diagnostics or related diagnostic products.
Proven track record of managing regulatory submissions and approvals for diagnostic devices, ideally within the pharmaceutical industry or with drug-diagnostic co-development programs.
Deep understanding of regulatory guidelines and requirements for in vitro diagnostics (IVDs), medical devices, and companion diagnostics, particularly in the U.S. (FDA) and EU (EMA).
Experience with global regulatory health authorities, including successful submissions and interactions with agencies such as FDA, EMA, and PMDA.
Strong project management and organizational skills with the ability to manage multiple complex projects simultaneously.
Demonstrated leadership and team management skills with experience leading regulatory teams.
Preferred
In-depth knowledge of U.S. and international regulatory frameworks for diagnostics and medical devices.
Strong analytical skills with the ability to interpret regulatory guidelines and communicate complex regulatory concepts clearly.
Excellent verbal and written communication skills for interaction with health authorities and cross-functional teams.
Ability to influence and collaborate with diverse teams, including clinical, R&D, commercial, and legal professionals.
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
2024-11-19
2024-11-12
Company data provided by crunchbase
