BeOne Medicines · 1 day ago
Associate Director, Regulatory CMC (Small Molecule)
United States
Full-time
Onsite
Lead/Staff, Director/Executive
$142K/yr - $192K/yr
8+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking an experienced regulatory professional to manage and complete regulatory projects. The role involves developing strategies, managing CMC-related regulatory submissions, and collaborating with cross-functional teams to ensure compliance with regulatory requirements.
Pharmaceuticals
Responsibilities
Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions for investigational, market, and post-approval applications
Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project
Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects
Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely
Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions
Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project
Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project
Provide comments on new global guidance through company’s commenting process
Qualification
Required
8+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience
Education Required: BA/BS Degree in scientific disciplines, MS/PhD preferred
A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries
In-depth knowledge of ICH requirements and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus
Demonstrated leadership as a people manager
Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management
Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.)
Excellent oral and written communications skills are a must-have
The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment
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