Talent.com
Principal Regulatory Affairs Specialist - Ad Promo
Principal Regulatory Affairs Specialist - Ad PromoDenver Staffing • Denver, CO, US
Principal Regulatory Affairs Specialist - Ad Promo

Principal Regulatory Affairs Specialist - Ad Promo

Denver Staffing • Denver, CO, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Opportunity At Bausch + Lomb

Bausch + Lomb 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. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

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 companies 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 companies 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.
  • We offer competitive salary & excellent benefits including :

  • 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.
  • This position may be available in the following locations : [[location_obj]]. 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.

    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.

    serp_jobs.job_alerts.create_a_job

    Regulatory Specialist • Denver, CO, US

    Job_description.internal_linking.related_jobs
    Aquestive Therapeutic Specialty Representative

    Aquestive Therapeutic Specialty Representative

    Inizio Engage • Denver, CO, US
    serp_jobs.job_card.full_time
    Aquestive Therapeutics is hiring directly for several key positions, with Inizio Engage supporting the recruiting process. With more than 20 years of pioneering patient-centered innovation, we'v...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Manager Oncology Research Pharmacy

    Manager Oncology Research Pharmacy

    MCKESSON • Denver, CO, United States
    serp_jobs.job_card.full_time
    It’s More Than a Career, It’s a Mission.Our people are the foundation of our success.By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have t...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Clinical Strategy Consultant - Remote

    Principal Clinical Strategy Consultant - Remote

    Stryker • Denver, CO, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    A leading medical technology company in Colorado seeks a Principal Clinical Consultant to leverage clinical expertise in supporting sales and driving business growth. The ideal candidate will have a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Specialist, Poison Information Pharmacist (Uncertified)

    Specialist, Poison Information Pharmacist (Uncertified)

    Denver Health • Denver, CO, United States
    serp_jobs.job_card.full_time
    We are recruiting for a motivated Specialist, Poison Information Pharmacist (Uncertified) to join our team!.We are here for life's journey. Where is your life journey taking you?.Being the heartbeat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Assoc Reg Affairs Specialist

    Assoc Reg Affairs Specialist

    Zimmer Biomet • Englewood, CO, United States
    serp_jobs.job_card.full_time
    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Principal Consultant, Advisory Services

    Principal Consultant, Advisory Services

    Diversified • Denver, CO, United States
    serp_jobs.job_card.full_time
    Principal Consultant, Advisory Services-.Diversified is a global leader in audio visual and media innovation, recognized for designing and building the world’s most experiential environments.Our aw...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Contract Specialist

    Contract Specialist

    US Government Jobs • Denver, CO, US
    serp_jobs.job_card.full_time
    This position is part of the WAPA Headquarters.As a Contract Specialist, you will be responsible for the pre- and post-award functions on simplified and complex, multidisciplinary supply, service, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    AVP, Pharmacy Commit Strategies

    AVP, Pharmacy Commit Strategies

    Vizient, Inc. • Centennial, CO, United States
    serp_jobs.job_card.full_time
    When you're the best, we're the best.We instill an environment where employees feel engaged, satisfied and able to contribute their unique skills and talents. We provide extensive opportunities for ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Head of Regulatory Affairs

    Head of Regulatory Affairs

    Confidential • Denver, CO, United States
    serp_jobs.job_card.full_time
    Top biotechnology (BioTech) company developing innovative treatments.The Company is seeking a Head of Regulatory Affairs to provide strategic leadership and oversight of all regulatory activities r...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    AVP, Pharmacy Commit Strategies

    AVP, Pharmacy Commit Strategies

    Vizient • Centennial, CO, United States
    serp_jobs.job_card.full_time
    When you're the best, we're the best.We instill an environment where employees feel engaged, satisfied and able to contribute their unique skills and talents while living and working as their authe...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Regulatory Compliance-Senior Consultant

    Regulatory Compliance-Senior Consultant

    Plante Moran • Denver, CO, United States
    serp_jobs.job_card.full_time
    Our "we-care" culture is more than just a motto; it's a promise.From day one, we prioritize your growth, well-being, and success. You can count on us to support your career journey and help you achi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Vice President of Regulatory Affairs

    Vice President of Regulatory Affairs

    Calibrant Energy • Denver, CO, US
    serp_jobs.job_card.full_time
    Vice President Of Regulatory Affairs.The Vice President of Regulatory Affairs will be a strategic leader responsible for defining, advocating, and executing the company's regulatory strategy across...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Advertising Compliance Specialist (Hybrid)

    Advertising Compliance Specialist (Hybrid)

    American Family Insurance • Denver, CO, United States
    serp_jobs.job_card.full_time
    As an Advertising Compliance Specialist, you will provides a full range of compliance oversight, advice and services with specialist knowledge in support of the business. You will focus on ensuring ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Consultant, Regulatory / ECMC Advisor (Oil & Gas) - Colorado

    Principal Consultant, Regulatory / ECMC Advisor (Oil & Gas) - Colorado

    Environmental Resources Management (ERM) • Denver, CO, United States
    serp_jobs.job_card.temporary
    Lead the Future of Environmental Compliance • • • •Why This Role Matters • •You’ll be the cornerstone of ERM’s Liability Portfolio Management and Remediation team, guiding clients through Colorado-specif...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Lead Regulatory Strategy Consultant – Oil & Gas (Remote)

    Lead Regulatory Strategy Consultant – Oil & Gas (Remote)

    ERM • Denver, CO, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    A global sustainability consultancy is looking for a Principal Consultant, Regulatory Strategy Advisor, to lead site investigation and remediation projects. The position requires 10+ years of experi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Principal Commercial Credit Officer - Tech and Life Science

    Principal Commercial Credit Officer - Tech and Life Science

    First Citizens Bank • Denver, CO, US
    serp_jobs.job_card.full_time
    This is a hybrid role, with the expectation that time working will regularly take place inside and outside of our NY, Boston, SF, Chicago, Denver or North Carolina (Raleigh / Charlotte) offices.Will ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal Consultant

    Principal Consultant

    Medium • Denver, CO, United States
    serp_jobs.job_card.full_time
    Stanley Consultants is an award-winning and industry-leading global consulting engineering firm, with an unmatched commitment to culture, values, and ethics. We are dedicated to client experience an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based

    Syneos Health / inVentiv Health Commercial LLC • Denver, CO, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Principal / Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA / Canada Remote Based.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to acceler...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted