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Lead Regulatory Affairs Strategist

2 months ago

Brockton, Massachusetts, United States Bausch & Lomb Full time
Company Overview:
Bausch + Lomb is a prominent global leader in eye health, committed to safeguarding and enhancing vision for millions worldwide. Our mission is straightforward yet impactful: to help individuals see better, thereby improving their quality of life. With a diverse portfolio of over 400 products, we cater to the comprehensive eye health needs of our customers throughout their lives.

Position Summary:
The Lead Regulatory Affairs Strategist is responsible for overseeing the comprehensive product strategy, documentation, compliance, and market expansion for consumer products, including Rx/OTC, OTC Monograph, Nutritional, and Cosmetics.

Key Responsibilities:
  • Analyze and interpret regulatory policies and guidelines, ensuring accurate application.
  • Innovate and develop strategies to enhance the likelihood of successful regulatory submissions.
  • Conduct thorough reviews of scientific data, ensuring clarity and support for conclusions.
  • Adapt 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, effectively guiding team members beyond direct reporting lines.
  • Collaborate with key opinion leaders and advisory boards to drive regulatory initiatives.
  • Advise project teams on regulatory strategies and serve as the primary contact for Health Authorities.
  • Review product formulations and raw materials, offering insights on regulatory compliance.
  • Utilize regulatory databases to ensure precise information for product labeling and compliance.
  • Mentor and coach team members in regulatory affairs expertise.
  • Represent Bausch + Lomb in industry forums and regulatory committees as needed.

Qualifications:
  • Bachelor's degree or equivalent experience preferred.
  • At least 8 years of experience in Regulatory Affairs within the consumer product sector.
  • In-depth knowledge of regulatory processes and systems.
  • Strong analytical and critical thinking abilities.
  • Exceptional organizational and communication skills, both verbal and written.
  • Proven business acumen with an understanding of drivers beyond Regulatory Affairs.
  • Ability to influence key stakeholders and manage multiple priorities effectively.
  • Strong interpersonal skills to foster positive relationships.
  • Experience in drafting regulatory documents for pre-market and post-market submissions.
  • Detail-oriented with a focus on accuracy and consistency in documentation.
  • Familiarity with FDA regulations and compliance requirements.
  • Proven capability to work independently and contribute to continuous improvement initiatives.

Benefits:
We offer a competitive salary and comprehensive benefits package, including medical, dental, and vision insurance, a 401K plan with company matching, paid time off, and an employee stock purchase plan.

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.