Beigene

Beigene

Senior Associate, US Regulatory Affairs

Remote (US) · Senior

Sponsorship not specified$94k-$124kDetected 19 days ago
GCPData AnalysisGMPFDA RegulatoryCommunicationProblem SolvingRegulatory Affairs

About the role

  • 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.
  • This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics.

Responsibilities

  • BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals.

Requirements

  • Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
  • Experience with CTD/eCTD.
  • Experience with publishing documents in Adobe Acrobat Professional.
  • Working knowledge of FDA and ICH regulatory guidance and regulations
  • Knowledge/experience with regulatory requirements for other regions also desirable
  • Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.
  • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
  • Participate on project teams and provide expertise on regulatory matters
  • Work with external regulatory consultants/CRO's as required
  • BA / BS in Health Science, preferred, with at least 2+ years ' experience in the pharmaceutical industry
  • Experience with CTD/eCTD. Experience with 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 also desirable
  • Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills
  • The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative

Compensation

  • $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.
  • 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.
  • The Sr Associate will 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.

Benefits

  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
  • 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.

Equal opportunity

  • We are proud to be an equal opportunity employer.
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This listing is sourced directly from Beigene's careers page and normalized into a canonical job model.