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Regulatory Affairs Project Lead I

2 months ago

Addison, Texas, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities :
  • Responsible for assisting in regulatory policy initiatives within the Regulatory Science and Policy division.
  • Comfortable operating in a matrixed environment and adept at navigating 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 issues, 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 various regulatory categories (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices).
  • Keep abreast of emerging regulatory policy developments, particularly those from North American regulatory bodies, legislative bodies, and the pharmaceutical sector, and pinpoint issues that may influence the Client's R&D pipeline, regulatory strategy, or product portfolio.
  • Deliver pertinent ad hoc regulatory insights to internal stakeholders, effectively communicate implications, and raise awareness of critical business issues to support informed decision-making, while collaborating with subject matter experts within the organization to evaluate impacts on Client products and objectives.
  • Organize and lead internal teams to formulate Client responses and feedback on proposed legislation, regulations, guidelines, and regulatory policy matters.
  • Maintain close collaboration with colleagues (R&D, External Affairs, etc.) who are leading policy initiatives in the external landscape to ensure regulatory input and overall alignment on Client positions.
  • Strategically plan and oversee interactions and communications with trade associations and health authorities regarding regulatory policy issues.
  • Spearhead proactive advocacy initiatives for Client priority regulatory policy areas, consulting with internal experts and leadership to identify key 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 execute proposed strategies.
Qualifications:
  • A minimum of a B.S. degree; M.S., Pharm D, MD, PhD, or equivalent preferred.
  • At least 6 years of relevant experience in a pharmaceutical regulatory role across all therapeutic areas (excluding manufacturing), with non-Client experience.
  • Proficiency in MS Office applications, particularly Excel and PowerPoint.
  • Established experience in regulatory affairs and effective collaboration skills.
  • Familiarity with the drug/biologic development and commercialization processes.
  • Exceptional time management and organizational abilities.
  • Self-driven, action-oriented, and results-focused, fostering an engaging and motivating work atmosphere.
  • Capability to lead multiple complex initiatives (short, mid, and long-term).
  • Strong writing skills, data analysis capabilities, and experience in drafting responses to FDA guidance documents.