Senior Manager, Regulatory Affairs

BeOne Medicines

. Plan and manage regulatory activities for assigned projects spanning clinical, non-clinical, and CMC technical areas .

Posted 9/29/2026full-timeRemote • United StatesSenior💰 $139,800 - $184,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory activities, including the preparation and submission of INDs, BLAs, and NDAs, while ensuring compliance with FDA and ICH regulations. Possesses strong planning and communication skills to effectively manage cross-functional teams and regulatory submissions.

Highest-signal resume keywords

IND PreparationRegulatory ComplianceFDA RegulationsCTD/eCTD ExperienceGMP, GLP, GCP Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Dossier PreparationIND SubmissionBLA/NDA SubmissionRegulatory Strategy DevelopmentRegulatory Archive Maintenance

Soft Skills

Excellent Communication SkillsSuperior Planning SkillsDetail-OrientedSelf-Starter

Tools & Technologies

Adobe Acrobat Professional

Industry Keywords

Regulatory ActivitiesPharmaceutical Product Life CycleCross-Functional Project TeamsRegulatory GuidanceRegulatory Consultants

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Plan and manage regulatory activities for assigned projects spanning clinical, non-clinical, and CMC technical areas
Assist in developing and implementing strategies for earliest possible approvals or clearance of regulatory submissions
Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers for product investigation and registration in the US and abroad
Ensure regulatory submissions remain compliant with regulatory requirements
Support and manage preparation of meeting requests and briefing documents
Manage preparation, review, and submission of INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, and other submission components
Participate on cross-functional project teams and provide regulatory expertise
Develop and maintain current regulatory knowledge and advise management on significant developments
Ensure compliance with departmental requirements and maintain the regulatory archive
Work with external regulatory consultants and CROs as required

Requirements

What you’ll need

7+ years’ related experience
BA/BS degree
Experience and knowledge in preparation of INDs (required)
Experience with NDAs (desirable)
Experience preparing supportive amendments and supplements covering manufacturing, nonclinical, and clinical areas
Experience with CTD/eCTD
Experience publishing documents in Adobe Acrobat Professional
Working knowledge of FDA and ICH regulatory guidance and regulations
Understanding of FDA structure and function
Knowledge/experience with regulatory requirements for other regions (desirable)
Working knowledge of GMP, GLP, and GCP regulations
Understanding of the pharmaceutical product life cycle
Excellent oral and written communication skills
Superior planning skills
Detail-oriented, self-starter comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

Benefits

Comp & perks

Annual bonus plan eligibility for Non-Commercial roles
Incentive compensation plan eligibility for Commercial roles
Discretionary equity awards opportunity
Voluntary participation in the Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness