Manager, Regulatory Compliance
BeOne Medicines
Global Program Regulatory Manager
Novartis
full-time
Posted on:
Location Type: Remote
Location: Remote • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $114,100 - $211,900 per year
Job Level
JuniorMid-Level
About the role
- Provide strategic and operational regulatory direction
- Support the RA global program team representative and/or Global Therapeutic Area Lead for programs through development, registration, and approval/post approval
- Ensure execution of regulatory plans in line with global regulatory strategy
- Contribute to global program regulatory strategy
- Coordinate regulatory readiness with other line functions, Country Organizations & Regions
- Lead planning, preparation and submission of clinical trials
- Lead implementation of the defined global registration strategy into regional submissions worldwide by country organizations
- Ensures timely RA input and submission of regulatory compliance and maintenance reports
Requirements
- Science based BS or MS with requisite experience and demonstrated capability
- Advanced degree (MD, Ph D, PharmD) preferred
- Experience with regulatory submission and approval processes in 1 or more major regions
- 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: Innovation in regulatory strategy, Understanding of post-marketing/brand optimization strategies and commercial awareness preferred, Involvement in dossier submissions and approvals, HA negotiations, Drug regulatory submission and commercialization in region, Analysis and interpretation efficacy and safety data, Regulatory operational expertise
- Strong interpersonal, communication, negotiation and problem solving skills
- Basic organizational awareness (e.g., interrelationship of departments, business priorities)
Benefits
- Full range of medical benefits
- Financial benefits
- Various paid time off benefits, such as vacation, sick time, and parental leave
- Sign-on bonus
- Restricted stock units
- Discretionary awards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionregulatory complianceclinical trialsregulatory strategydossier submissionsHA negotiationsdrug regulatory submissionsafety data analysisefficacy data interpretationregulatory operational expertise
Soft skills
interpersonal skillscommunication skillsnegotiation skillsproblem solving skillsorganizational awareness
Certifications
BSMSMDPhDPharmD
