BeOne Medicines
Senior Manager, Regulatory Affairs - US
Remote (US) · Senior
Sponsorship not specified$140k-$185kDetected 2 days ago
GCPData AnalysisGMPFDA RegulatoryCommunicationProblem SolvingRegulatory Affairs
Stay score
odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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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.
Requirements
- 7+ years' related experience is required with a BA/BS degree
- 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.
- Understanding of FDA structure and function
- 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
Compensation
- $139,800.00 - $184,800.00 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.
Benefits
- Entrepreneurial Mindset
- Continuous Learning
- 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.
Company info
- We are proud to be an equal opportunity employer.
- 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.
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This listing is sourced directly from BeOne Medicines's careers page and normalized into a canonical job model.