Lead Regulatory Affairs Specialist

2 weeks ago

Brockton, Massachusetts, United States Bausch + Lomb Full time

Bausch + Lomb is a premier global organization in eye health, committed to safeguarding and enhancing vision for countless individuals from birth through all stages of life. Our mission is straightforward yet impactful: to assist you in seeing better, thus living better.

We boast a diverse portfolio of over 400 products, meticulously designed to cater to our customers' comprehensive eye health requirements throughout their lives. Our esteemed brand is founded on the profound trust and loyalty of our customers, cultivated over our 170-year legacy. With approximately 13,000 employees and operations in nearly 100 countries, we extend our services to billions of potential clients worldwide. Our history is marked by significant advancements in eye health, and we are poised to continue leading in this vital field.

Position Objectives:

The incumbent will oversee the overall product strategy, documentation, market expansion, labeling content, regulatory compliance, and change management for consumer products, including Rx/OTC, OTC Monograph, Nutritional, and Cosmetics.

Key Responsibilities:

  • Interpret and apply Regulatory Authority policies, regulations, and guidance effectively.
  • Transform innovative concepts into successful regulatory submissions to enhance approval likelihood.
  • Conduct thorough reviews of scientific data, ensuring clarity and robust support for conclusions.
  • Respond swiftly to regulatory changes, providing strategic recommendations to mitigate business risks.
  • Engage with external regulatory stakeholders to influence the regulatory landscape.
  • Lead and manage projects, influencing team members beyond direct reporting lines.
  • Collaborate with key 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 compliance issues.
  • Utilize regulatory databases to ensure precise information for cosmetics, OTC Drug Facts, and nutritional products in the US and/or Canada.
  • Mentor and coach individuals on regulatory expertise.
  • Provide technical guidance as a subject matter expert.
  • Participate in external industry forums and represent Bausch + Lomb in committees and boards.

Qualifications:

  • Bachelor's degree preferred or equivalent experience.
  • A minimum of 8 years in Regulatory Affairs within the consumer product sector.
  • Comprehensive understanding of regulatory processes and information systems.
  • Proven analytical reasoning and critical thinking abilities.
  • Exceptional organizational and communication skills, both verbal and written.
  • Strong business insight and awareness of drivers beyond Regulatory Affairs.
  • Ability to influence key stakeholders and maintain effective relationships.
  • Proficient in managing multiple tasks and meeting deadlines.
  • Strong team collaboration skills.
  • Interpersonal skills to positively influence others.
  • Commitment to continuous learning and process enhancement.
  • Capacity to act decisively in unexpected situations.
  • Experience in drafting pre-market and post-market registration documents.
  • Detail-oriented with a keen eye for accuracy.
  • Familiarity with FDA regulations and the Code of Federal Regulations (CFR).
  • Ability to drive operational excellence and performance metrics.
  • Risk-aware with problem-solving capabilities.
  • Experience in understanding and applying US regulatory requirements for cosmetic products.
  • Familiarity with innovative approaches for Rx to OTC switches is preferred.

We offer a competitive salary and 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 (3 weeks, prorated upon hire), floating holidays, and sick leave.
  • Employee Stock Purchase Plan with company match.
  • Employee Incentive Bonus.
  • Tuition Reimbursement for select degrees.
  • Ongoing performance feedback and annual compensation reviews.

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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