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Regulatory Affairs Project Lead

2 months ago

Addison, Texas, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities :
  • Oversee and support regulatory policy initiatives within the Regulatory Science and Policy division.
  • Demonstrate proficiency in navigating a matrix organizational structure and managing uncertainty to facilitate decision-making across various teams.
  • Collaborate with regulatory leaders to provide cross-functional support on both strategic and operational product matters, including policy considerations, product/project strategies, FDA interactions, and other external engagement activities.
  • Ensure successful implementation of innovative consumer-focused products and manage the product life cycle across diverse 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 and the pharmaceutical sector, and assess their potential impact on the Client's R&D pipeline and regulatory strategy.
  • Deliver pertinent regulatory intelligence to internal stakeholders, effectively communicating critical business issues to support informed decision-making and collaborating with subject matter experts to evaluate implications for Client products and objectives.
  • Organize and lead internal teams to formulate Client responses and feedback on proposed legislation, regulations, guidelines, and regulatory policy matters.
  • Work closely with colleagues in R&D and External Affairs to align on policy activities and ensure regulatory input is integrated into the overall Client position.
  • Strategically plan and manage communications with trade associations and health authorities regarding regulatory policy issues.
  • Champion proactive advocacy initiatives for priority regulatory policy areas, consulting with internal experts and leadership to identify key issues.
  • In partnership with internal stakeholders, coordinate the company's policy positions across various groups, identify opportunities for engagement with regulatory authorities and trade associations, and implement proposed strategies.
Qualifications:
  • A minimum of a B.S. degree; M.S., Pharm D, MD, PhD, or equivalent is preferred.
  • At least 6 years of relevant experience in a pharmaceutical regulatory role across all therapeutic areas (excluding manufacturing), with experience outside of Client preferred.
  • Proficiency in MS Office applications, particularly Excel and PowerPoint.
  • Established experience in regulatory affairs and effective collaboration skills.
  • Strong understanding of the drug/biologic development and commercialization processes.
  • Excellent time management and organizational abilities.
  • Self-driven, action-oriented, and results-focused, fostering an engaging and motivating work environment.
  • Capability to lead multiple complex projects with varying timelines (short, mid, and long-term).
  • Proficient in writing, data analysis, and preparing research summaries, with prior experience in commenting on FDA guidance documents.