Regulatory Specialist I conducting regulatory activities for health care facilities across Florida. Prepares reports, manages files and provides support for QA reviews in the agency.
About the role
- Director of Global R&D Compliance at BeOne providing strategic compliance guidance in biopharmaceuticals. Leading efforts to sustain compliance culture and integrity in a rapidly evolving healthcare environment.
Responsibilities
- Serve as a trusted, strategic advisor to Global R&D stakeholders, providing real-time, practical compliance guidance.
- Participate in key meetings to offer risk-based insights on clinical, scientific, and research activities.
- Deliver tailored compliance training and communications to ensure alignment with internal policies, industry standards, and regulatory expectations.
- Provide compliance risk assessment, education, and oversight for Global R&D and Global Medical Affairs functions.
- Oversee the development, implementation, and maintenance of Global R&D compliance policies and related SOPs.
- Design, deliver, and evaluate engaging, role-based compliance training for R&D stakeholders.
- Conduct live and remote monitoring of R&D activities and provide timely feedback to stakeholders.
- Ensure interactions with HCPs, HCOs, study subjects, and patients comply with BeOne policies, SOPs, and industry standards.
Requirements
- Bachelor’s degree required; advanced degree (JD, MBA, MPH, or related scientific field) strongly preferred.
- 10+ years of relevant compliance, legal, or R&D experience in the biopharmaceutical or life sciences industry.
- Strong understanding of global clinical development, research operations, and global regulatory frameworks.
- Prior experience advising Global R&D or Medical Affairs functions preferred.
- Demonstrated ability to serve as a strategic, solutions-oriented business partner while maintaining independence and objectivity.
- Exceptional communication skills, with ability to influence, coach, and guide stakeholders at all levels.
- Strong analytical, problem-solving, and risk assessment capabilities.
- Ability to work autonomously and manage competing priorities in a dynamic environment.
- High degree of integrity, professionalism, and sound judgment consistent with OIG and DOJ expectations for effective compliance programs.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Discretionary equity awards
- Employee Stock Purchase Plan
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