Associate Director, Global Regulatory Project Management
United States · Remote OK
$147k–$197k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Associate Director, Group Leader, BeOne Institute, San Carlos, California
San Carlos, California, United States · Hybrid
$183k–$229k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Scientific Leadership, Drug Discovery, Cancer Biology, Cancer Immunology, Protein Engineering
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Pharmacovigilance, Signal detection, Safety data evaluation, Regulatory reporting, Risk management
About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting develop…
Senior Manager, Data Strategy and Field Tool Operations
San Carlos de Bariloche, Río Negro Province, Argentina · Remote OK
$142k–$187k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: SAP Ariba Upstream, SAP Ariba Downstream, Configuration, Root Cause Analysis, Incident Management
Account Manager – Targeted Accounts (Columbus & Grand Rapids)
Michigan, United States · On-site
$170k–$215k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Clinical Monitoring, ICH-GCP, Oncology, Site Management, Trial Master File
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Study Start-Up, ICH/GCP, Clinical Research, Site Feasibility, Regulatory Submissions
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: SAP Ariba CIG, SAP S/4HANA, SAP CPI, API Development, Middleware Integration
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Senior Director, Medical Affairs, Hemato-Oncology, Europe
Basel, Basel-City, Switzerland · On-site
$251k–$314k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Hemato-Oncology Expertise, Medical Affairs Strategy, KOL Relationship Management, Clinical Development, Lifecycle Management
Director, Medical Affairs, Hemato-Oncology, Europe
Basel, Basel-City, Switzerland · On-site
$209k–$262k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Medical Affairs, Hemato-Oncology, KOL Management, Clinical Development, Strategic Planning
Senior Director, Small Molecule Drug Product Manufacturing
Hopewell, New Jersey, United States · On-site
$201k–$271k/yr
Senior+$6.8B raised
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Small Molecule Drug Product Manufacturing, cGMP, FDA Compliance, EMA Compliance, Lean Manufacturing
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Strategic Feasibility, Site Identification, Patient Recruitment Planning, Disease Area Landscaping, Data Analysis
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, …
Skills: Identity and Access Management, Azure AD, Active Directory, Saviynt, Privileged Access Management
About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting develop…
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$147k–$197k/yr
Full-time
bachelor degree, postgraduate degree
Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance
Posted 13d ago
~40 hrs/week
Remote in United States
Responsibilities
The Associate Director leads global regulatory strategies and project management for drug development programs across multiple regions. They coordinate cross-functional teams to ensure timely and compliant regulatory submissions while driving process improvements and strategic business alignment.
Requirements
Candidates must possess a Bachelor's degree in Science or a related field and at least 8 years of experience in regulatory project management and submissions. Strong leadership, strategic thinking, and proficiency in project management tools are essential for this role.
Full job description
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description: The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and executing regulatory strategies across the global drug development lifecycle. This role blends deep regulatory expertise with advanced project management skills, driving successful NDA/BLA/MAA submissions and ensuring cross-functional integration across regions. The AD, Global RPM proactively anticipates regulatory challenges, influences business decisions, and champions process improvements to secure and maintain market access for products worldwide.
Essential Functions of the Job:
Strategic Global Leadership
Translate, implement, and advise on global regulatory strategies for development programs, ensuring alignment with business objectives and long-term vision across all major regions (US, EU, China, APAC, LATAM, etc.).
Act as a key advisor to the GRL/RRL, providing strategic regulatory oversight and recommendations for global product development, submissions, and lifecycle management.
Integrate functional expertise with business knowledge to solve complex problems and make sound decisions for the organization on a global scale.
Maintain awareness of global regulatory environments, policy trends, and competitive landscapes, assessing impact and adapting strategies accordingly.
Global Project Management Excellence
Lead and manage complex regulatory submissions (IND/CTA, NDA/BLA/MAA) across multiple regions, ensuring compliance with ICH, US, EU, China, and other international requirements.
Act as the (COO) to the Global Regulatory Lead, translating strategic regulatory vision into actionable project plans, driving operational execution, and ensuring all cross-functional activities are coordinated and delivered on time.
Organize and facilitate cross-functional meetings with global teams to coordinate, plan, and track submission activities, driving accountability and alignment among stakeholders worldwide.
Proactively identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy.
Oversee preparation and submission of documentation to support investigational and marketing registration packages, ensuring timelines and quality standards are met globally.
Cross-Regional Collaboration
Build partnerships with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC, commercial) across regions to achieve strategic business goals through knowledge sharing and collaboration.
Liaise and negotiate with cross-functional teams to expedite submission timelines and support resolve key regulatory issues in all relevant markets.
Mentor and guide junior staff in project planning, regulatory processes, and professional development, fostering a global mindset.
Continuous Improvement
Champion process optimization and improvement initiatives within the global regulatory PM function.
Contribute to the development and implementation of regulatory processes and policies, fostering a culture of excellence and innovation across regions.
Supervisory Responsibilities:
This role has the potential to evolve into a formal people-manager position. Over time, responsibilities may include:
Providing direct or indirect supervision to Regulatory Project Management staff, including mentoring, coaching, and supporting professional development.
Guiding and developing junior team members to support their growth and long-term success within the organization.
Overseeing cross-functional project teams and coordinating activities across global stakeholders.
Serving as a leader and role model within the Regulatory Project Management function, fostering a collaborative and high-performance culture.
Computer Skills:
Proficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BI.
Advanced skills in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
Ability to quickly learn and adapt to new software platforms and digital collaboration tools.
Experience with electronic document management systems and regulatory submission platforms is preferred.
Other Qualifications Experience:
Bachelor’s degree in Science or related discipline; advanced degree preferred.
Minimum 8+ years of experience in regulatory project management and regulatory submissions, including both small molecules and biologics, with significant global exposure.
Demonstrated experience in strategic regulatory leadership, with a proven track record of successful submissions and regulatory PM accomplishments in multiple regions.
Experience leading cross-functional and cross-regional teams, influencing senior stakeholders globally.
Strong business acumen, strategic thinking, and ability to integrate multiple sources of data for sound decision-making.
Excellent verbal and written communication skills; able to understand and translate complex regulatory issues clearly to internal and external stakeholders worldwide.
Skilled in conflict resolution, negotiation, and fostering open communication across cultures.
Proficiency with project management and document management tools (e.g., Smartsheets, MS Project, Power BI, MS Office suite).
PMP or similar certification preferred.
Key Attributes:
Proactive, not reactive; anticipates challenges and takes initiative to address them.
Demonstrates integrity, accountability, and strategic leadership.
Thrives in a global team environment and seeks excellence as the measure of success.
Able to balance multiple tasks, prioritize effectively, and meet deadlines across time zones and regions.
Travel:
Occasional international and domestic travel may be required to support global project teams, attend regulatory meetings, or participate in industry conferences.
Travel requirements will vary based on project needs and organizational priorities.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
Salary Range: $146,700.00 - $196,700.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
Effective March 17, 2025, The U.S. subsidiary of BeiGene, Ltd. has changed its name to BeOne Medicines USA, Inc. This change comes ahead of our anticipated global rebranding to BeOne Medicines Ltd. and redomiciliation to Switzerland, pending shareholder approval. The new name reflects our commitment to develop innovative medicines and partner with the global community to help as many patients with cancer as possible.
To learn more about BeOne Medicines, please follow our new LinkedIn profile @BeOne Medicines.
Offices: 55 Cambridge Parkway, Suite 700W, Cambridge, MA 02142, US · 55 Challenger Rd, Ridgefield Park, New Jersey 07660, US · 1840 Gateway Drive, 3nd Floor, San Mateo, CA 94404, US · 1900 Powell Street, Suite 500, Emeryville, CA 94608, US · 6A Jianguomenwai Avenue, 22nd Floor, Tower D, Chaoyang District, Beijing, China 100022, CN
Effective March 17, 2025, The U.S. subsidiary of BeiGene, Ltd. has changed its name to BeOne Medicines USA, Inc. This change comes ahead of our anticipated global rebranding to BeOne Medicines Ltd. and redomiciliation to Switzerland, pending shareholder approval. The new name reflects our commitment to develop innovative medicines and partner with the global community to help as many patients with cancer as possible.
To learn more about BeOne Medicines, please follow our new LinkedIn profile @BeOne Medicines.
Offices: 55 Cambridge Parkway, Suite 700W, Cambridge, MA 02142, US · 55 Challenger Rd, Ridgefield Park, New Jersey 07660, US · 1840 Gateway Drive, 3nd Floor, San Mateo, CA 94404, US · 1900 Powell Street, Suite 500, Emeryville, CA 94608, US · 6A Jianguomenwai Avenue, 22nd Floor, Tower D, Chaoyang District, Beijing, China 100022, CN