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Lead Regulatory Affairs Specialist

2 months ago

Brockton, Massachusetts, United States Bausch + Lomb Full time

Bausch + Lomb (NYSE/TSX: BLCO) stands as a premier global organization in eye health, committed to safeguarding and enhancing vision for millions from birth through all life stages. Our mission is straightforward yet impactful: to help you see better, to live better.

With a diverse portfolio exceeding 400 products, we are fully equipped to address our customers' comprehensive eye health requirements throughout their lives. Our esteemed brand has earned the deep trust and loyalty of our customers, cultivated over our 170-year legacy. We boast a significant global presence with around 13,000 employees and operations in nearly 100 countries, reaching billions of potential customers worldwide. Our history is marked by pivotal advancements in eye health, positioning us to continue leading the charge in this vital field.

Position Objectives:

Oversee the comprehensive product strategy, including reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence, and change management for consumer products (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics).

Key Responsibilities:

  • Interpret and apply Regulatory Authority policies, regulations, and guidance accurately.
  • Transform innovative concepts into successful regulatory submissions to enhance the likelihood of approval.
  • Conduct thorough reviews of scientific data, ensuring clarity in technical arguments and robust support for conclusions.
  • Respond swiftly to regulatory changes, providing strategic recommendations to mitigate business risks.
  • Engage with external regulatory stakeholders to influence and shape the regulatory landscape.
  • Lead and manage projects effectively, influencing team members beyond direct reporting lines.
  • Collaborate with key national opinion leaders and advisory boards.
  • Guide project teams on regulatory strategy.
  • Serve as the primary contact for Health Authorities, managing these critical relationships.
  • Review raw materials and formulations, advising product development teams on regulatory compliance issues.
  • Utilize various regulatory databases to ensure accuracy in creating cosmetics, OTC Drug Facts, and nutritional/natural health products in the US and/or Canada.
  • Mentor and coach individuals on regulatory expertise.
  • Provide technical expertise as a subject matter expert, both internally and externally.
  • Participate in external industry forums, influencing the broader regulatory community.
  • Represent Bausch + Lomb in external committees and boards as necessary.

Qualifications:

  • Bachelor's degree preferred or equivalent experience.
  • A minimum of 8 years in Regulatory Affairs, specifically within the consumer product sector (Rx/OTC, OTC Monograph, Nutritional, and/or Cosmetics).
  • In-depth understanding of regulatory processes and information systems.
  • Proven analytical reasoning and critical thinking capabilities.
  • Exceptional organizational and communication skills, both verbal and written.
  • Strong business acumen with the ability to recognize business drivers beyond Regulatory Affairs.
  • Ability to influence key internal and external stakeholders and KOLs.
  • Proficient in managing multiple tasks and meeting deadlines.
  • Strong team collaboration skills.
  • Ability to support both internal and external business stakeholders.
  • Excellent interpersonal skills with a positive influence on others.
  • Demonstrated commitment to continuous learning and process improvement.
  • Capacity to react promptly and decisively in unforeseen situations.
  • Experience in authoring pre-market and post-market registration documents.
  • Detail-oriented with a keen eye for proofreading and ensuring document accuracy.
  • Familiarity with FDA regulations and the Code of Federal Regulations (CFR).
  • Focused on promoting operational excellence and performance metrics.
  • Risk-averse with the ability to identify solutions to complex challenges.
  • Ability to work independently on various activities.
  • Experience with the interpretation and application of US regulatory requirements for cosmetic products (MoCRA), including state-specific and CPSC requirements is preferred.
  • Experience with innovative approaches and general regulatory requirements for Rx to OTC switch is preferred.

We offer competitive salary & excellent benefits including:

  • Medical, Dental, Eye Health, Disability, and Life Insurance starting on your hire date.
  • 401K Plan with company match and ongoing contributions.
  • 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 for select degrees.
  • Ongoing performance feedback and annual compensation review.

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.

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.