Associate Director of Regulatory Affairs

Associate Director of Regulatory Affairs

Requirements

• A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatory
• Minimum of 6 years experience with regulatory submissions (e.g. Investigational New Drug Applications(INDs), New Drug Applications (NDA/NDS/MAA), Clinical, CMC, post marketing measures, Paediatric Investigation Plans (PIP)/(PSP) and Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME activities) are mandatory
• Strong understanding of regulatory strategy (Clinical, CMC) and implementation of operational activities
• Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams

Responsibilities

• Build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdiction (e.g. EU, US, UK and other) for the global development of products through all stages of development and post approval
• Manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment (immediate and long term impact on program)
• Create and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.)
• Collaborate with strategic operations and other functions (e.g. Clinical, CMC, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program
• Serve, as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders
• Review and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment
• Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions

Preferred Qualifications

No preferred qualifications provided.