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Lead Specialist in Regulatory Affairs

2 months ago

San Diego, California, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Oversee and support regulatory policy initiatives within the Regulatory Science and Policy team.
  • Demonstrate proficiency in navigating a matrix organization and managing uncertainty to facilitate decision-making across various teams.
  • Collaborate with regulatory leads to provide cross-functional support on both strategic and operational product matters, including policy, product/project strategy, FDA interactions, and other external engagement efforts.
  • Ensure successful implementation of innovative consumer-focused products and manage the product life cycle across various regulatory categories, including OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices.
  • Stay informed on emerging regulatory policy developments, particularly those from North American regulatory bodies, legislative bodies, and the pharmaceutical sector, and assess their potential impact on R&D pipelines, regulatory strategies, or product portfolios.
  • Deliver pertinent regulatory intelligence to internal stakeholders as needed.
  • Communicate the implications of business-critical issues effectively, raising awareness for informed decision-making, and collaborate with subject matter experts to evaluate impacts on products and objectives.
  • Organize and lead internal teams to formulate responses and feedback on draft legislation, regulations, guidelines, and regulatory policy matters.
  • Work closely with colleagues in R&D and External Affairs to ensure regulatory input aligns with overall policy activities in the external landscape.
  • Strategically plan and manage interactions with trade associations and health authorities regarding regulatory policy issues.
  • Champion proactive advocacy initiatives for key regulatory policy areas.
  • Consult with internal experts and leadership to pinpoint priority regulatory issues.
  • In partnership with internal experts and stakeholders, coordinate the company's policy positions across various stakeholder groups, identify or create engagement opportunities with regulatory authorities and trade associations, and implement proposed strategies.
Qualifications:
  • A minimum of a B.S., M.S., Pharm D, MD, PhD, or equivalent is preferred.
  • At least 3 years of experience in Regulatory Affairs.
  • Proven regulatory expertise.
  • Strong collaborative skills.
  • Familiarity with the drug/biologic development and commercialization processes.
  • Exceptional written, verbal, and presentation communication abilities; strong command of English (both written and spoken).
  • Excellent time management and organizational capabilities.
  • Ability to lead multiple complex projects across short, mid, and long-term timelines.
  • Self-driven, action-oriented, and results-focused, fostering an engaging and motivating work environment.