Lifelancer · 20 hours ago
Senior Manager Regulatory Affairs - Labeling, Advertising and Promotions
United States
Full-time
Remote
Senior Level, Lead/Staff
$160K/yr - $200K/yr
10+ years expNestlé Health Science is committed to merging nutrition, science, and wellness to empower healthier lives. The Regulatory Affairs Advertising, Promotion, and Labeling Lead will manage regulatory strategy and material approvals, ensuring compliance and supporting product launches throughout the product lifecycle.
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No H1B
Responsibilities
Guide, direct and coordinate the strategic labeling/advertising/promotion and planning for company products from a regulatory perspective for pre and post launch campaigns including strategic label development from target product profile (TPP), company core data sheet (CCDS) end to end development and maintenance
Maintain oversight and efficiency of Veeva promotional, label systems for managing review and approval of labeling and advertising/promotional materials
Lead and manage periodic meetings, metrics for labelling charter. Provide input into or develop required processes, including transitioning of acquired products into company systems and associated standard operating procedures to ensure consistency of approach and regulatory compliance for areas of responsibility
This position has responsibility for overseeing staff, coordinating with cross functional teams in assembling regulatory documents such as pre-IND, IND and efficacy supplements by clearly articulating key regulatory considerations for review and submission to Competent Health Authorities and other regulatory agencies (as requested)
Organize cross functional team meetings on management of change controls, labeling supplements and implementation of new/changes to approved product labels, prescribing information, medication guides, patient information leaflets and carton/container artworks
Direct point of contact and signatory for FDA APLB (Advertising Promotion Labeling Branch) submissions and advisory comments for all BLAs (Biological License Applications) and commercial products
Qualification
Required
Bachelor's degree in science with 10+ years of broad professional experience gained from previous Regulatory Affairs roles
Demonstrated, hands-on experience leading, managing, and preparing regulatory submissions and knowledge in the preparation of electronic submission
Experience in reviewing and approving change controls, advertising and promotion as well as non-promotional materials within a complex specialty/branded commercial pharmaceutical organization
Good interpersonal skills as well as a sound strategic business perspective with appropriate consideration to risk
Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly in North America
Preferred
Regulatory affairs certified (RAC) preferred
Preferred candidates will have experience in critically reviewing and implementing collaborative solutions to diverse promotional and MRL scenarios
In-depth understanding of the product commercialization and labeling development process is desired
Benefits
Performance-based incentives
A competitive total rewards package
401k with company match
Healthcare coverage
Broad range of other benefits
Company
Lifelancer
Lifelancer is a global platform for talent hiring in Life Sciences, Pharma, Healthtech & IT
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.68M2025-03-01Pre Seed· $0.24M
2024-03-01Pre Seed· $0.11M
2023-03-01Pre Seed· $0.12M
Leadership Team
J
Jayesh Pandya
Co-Founder & CEO
Company data provided by crunchbase