Job Description

dicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.

Position Overview:

The Senior Director of Regulatory Affairs and Quality is a hands-on leadership role. The position will have the responsibility to lead, manage and drive regulatory and quality (GxP) activities, policy and strategy, to interface with global regulatory agencies and corporate partners, and to provide executive management with regulatory metrics and information.

Key Duties and Responsibilities:

• Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
• Serve as Regulatory Affairs contact for external parties (for example, CROs, advisors) involved in the conduct of global clinical trials
• Develop and implement global regulatory strategy for submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, US FDA, EMA, PMDA, ICH, ISO)
• Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to Health Authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products
• Liaison with Health Authorities as needed
• Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Communicate project updates and risks to senior management and stakeholders across the organization
• Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Coordinate and prepare responses to requests for information from Health Authorities
• Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Maintain and develop standard operating procedures (SOPs) to ensure compliance with global GxP expectations.
• Oversee vendor qualification and oversight program
• Assess and manage internal regulatory and quality resources, including external consultants to ensure corporate objectives are met and risks are appropriately considered.

Requirements:

• Advanced Degree (PharmD, PhD, MPH, or equivalent) in a scientific field preferred
• 10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization
• Experience in development of SOPs and managing quality issues
• Experience in hosting and leading FDA and other regulatory authority audits, would be an advantage.
• Leadership and management experience in building high-performing teams through coaching and development
• Experience from IND through to marketing application, across all disciplines (nonclinical, clinical, CMC), as well as attending/running regulatory interactions