Senior Director of Regulatory Affairs

4 weeks ago


Parsippany, New Jersey, United States Melinta Therapeutics Full time
Job Summary

The Senior Director of Regulatory Affairs provides strategic leadership and formulates comprehensive regulatory strategies for product development and life cycle management of approved products, ensuring ongoing compliance with applicable regulatory requirements.

Key Responsibilities
  • Provides high-level strategic leadership and direction for regulatory activities, including submission preparation, defense, and interactions with regulatory authorities for new and ongoing clinical and surveillance programs, including labeling negotiations
  • Oversees and interprets regulations, guidelines, procedures, and policies related to the development and global registration of drug products, with a specific focus on clinical development and global registration
  • Leads and advises regulatory and clinical teams, providing expert guidance to clinical CROs, regulatory vendors, and area authors/reviewers on submission and dossier requirements
  • Acts as the primary point of contact with regulatory authorities, fostering strong working relationships with internal clinical team partners, project consultants and contractors, and external CROs
  • Develops and implements comprehensive regulatory strategies and operations, ensuring timely delivery of all regulatory submissions
  • Creates and executes detailed regulatory submission project and resource plans, sets goals, and tracks progress towards critical milestones for major regulatory submissions
  • Provides regulatory insights and input into new business venture activities, contributing to strategic decision-making
  • Effectively addresses and resolves regulatory authority and business partner questions and concerns, ensuring compliance and alignment with business objectives
Requirements
  • Bachelor's degree or equivalent in life sciences or related discipline
  • Full lifecycle experience from early development to managing marketed products
  • Strong project management and computer skills (including Microsoft office)
  • Demonstrated strong leadership and management skills; proven ability to work with very little guidance/supervision with a proactive approach
  • Global regulatory management experience
  • Knowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicines
  • Highly collaborative and works with ease in matrix environment
  • Minimum of 10 years pharmaceutical experience 8 years regulatory experience in in drug development and registration activities


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