Senior Associate, 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.
Essential Functions of the job:
•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,withatleast2+ 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
Salary Range: $93,600.00 - $123,600.00 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