INACTIVE
Full-Time
Principal Regulatory Affairs Specialist
Ad Promo
Posted on 11/15/2025
Bausch Lomb
Compensation Overview
$95k - $145k/yr
+ Bonus
No H1B Sponsorship
Bridgewater Township, NJ, USA
In Person
Category
 Legal & Compliance (2) |
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Required Skills
Word/Pages/Docs
Marketing
Excel/Numbers/Sheets
Requirements
- Bachelor degree preferred or equivalent
- Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment
- 2+ years of advertising and promotional experience relevant to prescription drugs, dietary supplements, cosmetics and/or OTC drugs
- Strong working knowledge of regulatory guidelines, development and commercialization of products
- Strong organizational skills and excellent in managing multiple priorities
- Excellent communication skills (oral and written)
- Computer literacy – Microsoft Word, Excel, and Outlook; Adobe Acrobat
- Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility and flexibility
- Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory success
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data
- Knowledge of current and emerging issues and trends
- Ability to communicate effectively with regulatory authorities on the company’s behalf
- Strong interpersonal skills with the ability to influence others in a positive and effective manner, without authority
- Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines
Responsibilities
- Responsible for ensuring all promotional, educational, and training materials used in conjunction with the promotion of products conform to all applicable laws and regulations.
- Provides regulatory review and approval of advertising and promotional materials, new campaigns and launch strategies.
- Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
- Monitors FDA and FTC activity (as appropriate) including enforcement actions, guidance documents, etc. to analyze impact on Company products and communicates risk to Promotional Review Committee (PRC).
- Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
- Monitors competitor advertising to keep abreast of market promotional and advertising strategies.
- Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct competitor-to-competitor challenges
- Continually assesses the advertising and promotion related process to enhance efficiencies, compliance and assist with ongoing regulatory training related to products.
- Works closely with the Regulatory Affairs labeling group in order to assess and determine the impact of proposed labeling changes on product promotion.
- Communicate with regulatory authorities on the company’s behalf.
- Actively leads and/or participates in team activities.
Desired Qualifications
- None
INACTIVE