Bausch + Lomb
Principal Regulatory Affairs Specialist – Ad Promo
Bausch + Lomb, Carson City, Nevada, us, 89702
Bausch Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.
Objectives: Responsible for ensuring all promotional, educational, and training materials used in conjunction with the promotion of products conform to all applicable laws and regulations.
Responsibilities:
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.
Qualifications:
Bachelor degree preferred or equivalent.
Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment.
2 years of ad/promo 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 Package including Word, Excel, and Outlook; Adobe Acrobat.
Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy & 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.
Benefits:
Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date.
401K Plan with company match and ongoing company contribution.
Paid time off vacation (3 weeks – prorated upon hire), floating holidays and sick time.
Employee Stock Purchase Plan with company match.
Employee Incentive Bonus.
Tuition Reimbursement (select degrees).
Ongoing performance feedback and annual compensation review.
Location: This position may be available in the following location(s): [[location_obj]]
Compensation: For U.S. locations that require disclosure of compensation, the starting pay for this role is between$95,000 and $145,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
EEO Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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Objectives: Responsible for ensuring all promotional, educational, and training materials used in conjunction with the promotion of products conform to all applicable laws and regulations.
Responsibilities:
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.
Qualifications:
Bachelor degree preferred or equivalent.
Minimum of 6 years in Regulatory Affairs or relevant experience in a regulated environment.
2 years of ad/promo 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 Package including Word, Excel, and Outlook; Adobe Acrobat.
Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy & 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.
Benefits:
Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date.
401K Plan with company match and ongoing company contribution.
Paid time off vacation (3 weeks – prorated upon hire), floating holidays and sick time.
Employee Stock Purchase Plan with company match.
Employee Incentive Bonus.
Tuition Reimbursement (select degrees).
Ongoing performance feedback and annual compensation review.
Location: This position may be available in the following location(s): [[location_obj]]
Compensation: For U.S. locations that require disclosure of compensation, the starting pay for this role is between$95,000 and $145,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
EEO Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
#J-18808-Ljbffr