Opus Regulatory Inc. · 1 week ago
Principal Consultant Regulatory Affairs, Advertising and Promotion
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
6+ years expOpus Regulatory, Inc. is a niche firm providing experts in Regulatory Strategy, CMC, Labeling, Ad Promo and Medical Review. They are seeking several Principal Consultants in Regulatory Affairs Advertising + Promotion to manage regulatory requirements for drug products and provide leadership on advertising and promotional materials.
AdvertisingConsultingPharmaceutical
Responsibilities
Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc. in conjunction with client leadership
Provide strategic and operational leadership for promotional, educational, and investigative communications
Review and evaluate materials submitted by client teams to ensure that the content, quality, and format comply with applicable laws, regulations, and client policy
Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support clients' corporate goals
Manage launch preparation of promotional material for one or more products
Provide support and guidance to regulatory teams on RA requirements for one or more drug products
Maintain knowledge of changing regulatory requirements and advise teams as appropriate
Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects
Qualification
Required
Must have a minimum of 6 years of experience in pharmaceutical regulatory affairs specializing in Advertising and Promotion
Bachelor's degree required; Advanced degree in a science discipline preferred
Experience across multiple therapeutic areas is highly desirable
Demonstrated global and international experience is required
Proven project management skills to support the planning and coordination of regulatory submissions and appropriate regulatory inspections
Ability to work independently and innovatively in tackling operational challenges
Preferred
Advanced degree in a science discipline preferred
Experience across multiple therapeutic areas is highly desirable
Company
Opus Regulatory Inc.
Opus Regulatory is a niche consulting firm headquartered in the Seaport district of Boston.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Dave Sawyer
CEO/Founder
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