Sr. Director of Regulatory Affairs

  • Job DurationMore than 06 months
  • Project LevelExpert Experience Required

Project detail

Key Responsibilities

  • Guide the development, planning, and execution of regulatory submission strategies in line with corporate and program goals and timelines through alignment of key activities
  • Lead the preparation and filing of regulatory documentation (e.g., INDs, IMPDs, NDAs, meeting requests and briefing documents) for compliance with regulatory guidance and alignment with program-level regulatory strategy
  • Lead the interactions with regulatory agencies including tracking of progress of review, coordinating responses to questions, and closing out required actions
  • Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
  • Provide regulatory guidance and oversight of external CMOs to ensure all development and commercial activities are in compliance with applicable current regulations and guidance documents
  • Review internal and CMO-generated change controls and controlled documents to provide regulatory impact assessments and strategic guidance on implementation
  • Ensure continued regulatory compliance through adherence to change control procedures and completion of regulatory impact assessments
  • Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs
  • Provide guidance to the internal Publication Review Committee to ensure that outside communications abide with Regulatory requirements
  • Liaise externally with vendors, licensors and joint development collaborators


  • Experience with unique drug delivery mechanisms/dispensers is highly valued
  • Bachelor’s degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science, Engineering) and/or technical discipline. Graduate degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science, Engineering) and/or technical discipline preferred.
  • 7+ years of related pharmaceutical industry experience with relevant technical experience (e.g. QA, Technical Services, Operations, Manufacturing or R&D) with at least 4 of those years directly in regulatory affairs
  • Extensive knowledge of US and global regulatory requirements
  • Must be knowledgeable in industry trends for report and dossier preparation (e.g., IND/CTA/NDA/MAA, including electronic document submissions (i.e., eCTD).
  • Proficient in pertinent software & tools
  • Strong understanding of pharmaceutical development
  • Strong time and project management skills
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
  • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment
  • Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
  • Able to understand and interpret data/information and its practical application
  • Strong communication skills (e.g., clear and concise), team player, proven negotiation skills
  • Travel up to 25%

Industry Categories