Associate Director, Regulatory Affairs

Responsibilities

• Represent Regulatory Affairs on cross-functional program teams for assigned programs
• Lead day-to-day regulatory activities, maintain accurate regulatory documentation and timelines and contribute to development and execution of global regulatory strategies
• Prepare and review regulatory submissions including INDs, CTAs, amendments, and briefing documents, and marketing applications
• Support meeting preparation with health authorities, including FDA, to facilitate assessment of IND applications
• Coincide responses to Health Authority queries
• Proactively monitor for and anticipate risks; develop effective mitigation strategies to identified risks; assess likelihood of technical success for proposed solutions
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner
• Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects, providing guidance to the team to ensure developmental plans align with regulatory expectations
• Maintain awareness of changes in regulatory requirements and medical innovation in the relevant therapeutic areas; assess their potential impact and provide guidance to educate and inform project team(s) and leadership decisions
• Provide strategic and tactical advice to internal teams to achieve timely and efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements
• Participate in or lead departmental and cross-functional task forces and initiatives
• Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions

Qualifications

• Bachelor’s degree in a science field such as Biology, Chemistry, or Pharmaceutical Sciences. Advanced degree preferred, but not required
• Minimum of 10 years of increasing responsibility in Regulatory Affairs within the biopharmaceutical industry, or 5 years of experience plus an advanced degree (e.g., PhD, PharmD, JD)
• Demonstrated experience in the development, submission, and registration of new drugs (biologics, innovative medicines, drug/device combination products, etc.) in the US, EU and/or international countries
• Proven experience in the review, authoring, and/or managing of components of regulatory submissions such as of INDs, CTAs, NDAs/BLAs or MAAs, and their maintenance
• Experience contributing to strategic development related to new drug development, commercial support, partner management, as well as product lifecycle management activities
• Strong communication and interpersonal skills needed to influence decision-making in a diplomatic manner, particularly in relation to regulatory strategies
• Strong oral and written communication, time management, and team-oriented leadership skills are essential
• Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
• Proven mindset of proactive continuous improvement
• Strong attention to detail
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)