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Senior Associate, Regulatory Affairs – Promotional Operations
BeOne MedicinesSenior Associate managing regulatory promotional operations at BeOne, an oncology company. Driving standards and supporting regulatory submissions of promotional materials.
About the role
Key responsibilities & impact- Assist in driving standards, planning, coordination, and processing of promotional materials
- Support preparation of regulatory submissions for advertising and promotional materials
- Act as a centralized knowledge hub of Promotional Review Committee (PRC)
- Provide guidance on the submission process and materials review
- Manage review priorities against business needs and assist in material triage
- Ensure readiness of materials according to established criteria
- Drive the process within the document management system (Veeva PromoMats)
- Collaborate with Global Regulatory Operations for submissions in accordance with FDA requirements
- Contribute to modification, development, and implementation of company practices and policies
- Assist with periodic regulatory compliance audits
- Train stakeholders on PRC process
Requirements
What you’ll need- BA/BS degree (preferably in a scientific or health-related discipline)
- Minimum of 2+ years of direct experience in a Regulatory function or equivalent
- General knowledge of advertising/promotional regulations, guidelines, and best practices
- Strong business acumen and decision-making ability
- Proven ability to deliver on goals within a cross-functional team/partnership environment
- Excellent oral and written communication skills
- Superior planning skills
- Detail-oriented and self-starter
Benefits
Comp & perks- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Employee Stock Purchase Plan
- Discretionary Equity Awards
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionspromotional materials reviewdocument management systemVeeva PromoMatsregulatory compliance auditsadvertising regulationspromotional guidelinesbest practices
Soft Skills
business acumendecision-makingcross-functional collaborationoral communicationwritten communicationplanningdetail-orientedself-starter
Certifications
BA/BS degree