Associate Manager, US Regulatory Affairs

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.

GeneralDescription:

BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissionsandprovideguidancetocross-functionalteamsonregulatorystrategyandtactics.TheSrAssociatewill assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive.

EssentialFunctionsofthejob:

• Withminimalsupervision,planandmanageregulatoryactivitiesrelatedtoassignedprojectsthatspantechnical areas including clinical, non-clinical, and CMC
• Assistindevelopingandimplementingstrategiesfortheearliestpossibleapprovals/clearanceofregulatory submissions associated with assigned projects
• Managethepreparation,includingwritingasnecessary,assembly,review,andtimelysubmissionofregulatory dossiers as required for investigation and registration of products in the US and abroad
• Ensureregulatorysubmissionsaremaintainedincompliancewithregulatoryrequirements.Supportandmanage preparation of meeting requests and briefing documents
• Managethepreparation,review,andsubmissionofallcomponentsofregulatorysubmissionsincludingINDsand amendments,BLAs/NDAsandsupplements,annualreports,safetyreports,etc.Participateonprojectteamsand provide expertise on regulatory matters
• Developandmaintaincurrentregulatoryknowledgeandadvisemanagementofsignificantdevelopments.Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required

Qualifications:

• BA/BSinHealthScience,preferred,withatleast4+ years’experienceinthepharmaceuticalindustry
• ExperienceandknowledgeinpreparationofINDs(required)andNDAs(desirable),andsupportiveamendments and supplements (manufacturing, nonclinical, clinical)
• ExperiencewithCTD/eCTD.ExperiencewithpublishingdocumentsinAdobeAcrobatProfessional.Working knowledge of FDA and ICH regulatory guidance and regulations
• UnderstandingofFDAstructureandfunction.Knowledge/experiencewithregulatoryrequirementsforotherregions also desirable
• WorkingknowledgeofGMP,GLP,andGCPregulationsaswellanunderstandingofthepharmaceuticalproduct life cycle. Excellent oral and written communications skills are a must as are superior planning skills
• Thecandidateshouldbedetail-oriented,aself-starter,andbecomfortablewithbroadresponsibilitiesinan entrepreneurial, fast-paced, small company environment

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

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 [email protected].