Director, Regulatory Affairs

Rockville, MD, United States
Apr 08, 2021
Required Education
Position Type
Full time
Job Summary:

The Director, Regulatory Affairs is responsible for regulatory affairs for specific drug development programs (pre and post market approval). Develops and implements regulatory strategies. This individual may be responsible for overseeing technical areas such as labeling, operations, and/or regulatory intelligence. This is a hands-on position. Works under general direction.

Job Duties :
  • Develops and implements regulatory strategies and tactical work plans throughout development phases including filings and approvals of global market applications
  • Presents and defends regulatory plans to Senior Management
  • Provides oversight and direction to the company regarding content and clarity of information presented in regulatory submissions, ensuring timely preparation of organized and scientifically valid applications
  • Leads the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, NDA's, fast-track/breakthrough/accelerated approval/orphan drug applications. Ensures effective data presentation, data integrity, product performance claims, and quality scientific data against regulatory requirements
  • Develops effective professional relationships and promotes a positive company image with FDA and global regulatory authorities
  • Leads and/or participates regulatory interactions with and presentations to US FDA and other regulatory agencies
  • Proactively ensures compliance with all relevant regulations and guidelines; h as primary responsibility for audit readiness and response during inspections
  • Identifies and assesses regulatory risks, understanding global imperatives including market-related drivers; plans and implements appropriate mitigation strategies
  • Provides oversight, interpretation, support, training, and key input to staff on interpretation of regulatory strategies, GXP regulations, regulatory guidelines, corporate standards, and policies
  • Negotiates, interacts with and oversees the activities of contract organization in the preparation of regulatory documents and submissions
  • C omplies with all applicable policies regarding health, safety, and environmental policies

Job Requirements:
  • MS in life sciences or related area and at least 10 years of experience in regulatory affairs in a pharmaceutical or biotech organization; 7 years in a managerial role; or equivalent. PhD desired
  • Proven experience with US NDA submissions, preferably in Oncology/Hematology
  • Must have experience developing and successfully executing regulatory strategies; and d emonstrated understanding of ICH regulations and processes as they apply to drug development
  • Must have experience interacting and communicating with major regulatory agencies in all development stages and proven ability to discuss scientific aspects of program with them
  • Advanced knowledge and experience in the drug development process
  • Must have strong business acumen and demonstrate diplomacy in all interactions
  • Demonstrated leadership and management skills
  • Must have broad working knowledge of GCP, GMP, GLP
  • Demonstrated outstanding communication skills, including presentation, written, and interpersonal; e xperience writing scientific and technical documents
  • Strong negotiation, analytical, and problem solving skills
  • Proven ability to manage multiple priorities and projects
  • Proficiency in Microsoft Word and Excel, PowerPoint and Adobe Acrobat
  • Ability to travel approximately 10-20% [domestic and international]