Associate Director, Regulatory Science

Role Overview

• Act as US regulatory lead on assigned program(s)
• Work in close partnership with the Global Regulatory Lead(s) and under the oversight of the Executive Director, Regulatory Science to provide necessary regulatory inputs to the related cross-functional program teams
• Develop the US regulatory strategy under the oversight of the Executive Director, Regulatory Science, including any innovative procedures to expedite the path to approval, in line with corporate goals, in partnership with the Global Regulatory Lead(s) and the program regulatory team(s)
• Help identify regulatory risks, develop mitigation strategies, and support proactive agency engagement plans.
• Support integrated regulatory planning across clinical, nonclinical and chemistry and manufacturing,
• Execute the US regulatory strategy:
• Be the primary liaison with US regulatory authorities for the assigned program(s)
• Plan, prepare, and review submissions to the FDA, including Orphan designation applications (ODD), Investigational New Drug (IND) applications, Fast Track/RMAT designations, and Pediatric study plans
• Prepare FDA meeting requests, briefing documents, coordinate and prepare cross-functional teams for meetings, and interface with US regulatory authorities
• Coordinate and prepare responses to questions and requests for information from US regulatory authorities
• Ensure that regulatory documents are accurate, complete, compliant with applicable regulatory requirements and prepared in accordance with the defined timelines
• Actively participate in regulatory compliance and regulatory team development:
• Monitor, analyze, and disseminate intelligence on US regulatory matters that may affect ongoing development programs
• Lead the implementation of new US regulations/guidelines applicable and relevant to development programs in close collaboration with the Global Regulatory Lead(s) and relevant functional leads
• Contribute to updates, improvements and development of processes (including new SOPs as applicable) linked to regulatory activities
• Participate in internal audits and future HA inspections
• Share expertise and learning experiences
• “grow together” approach within the regulatory team.

Requirements

• Significant experience in the development and execution of US regulatory strategies for development programs in industry‑related US Regulatory Affairs
• Knowledge and experience of development/registration of biologics and/or Advanced Therapy Medicinal Products (ATMPs) is a plus
• Very good knowledge and understanding of US CFR and FDA guidelines is a must – understanding of EMA regulations and guidelines is a plus
• Previous experience in using US innovative expedited paths to approval in the frame of global development is a plus
• Track record of INDs preparation, management up to FDA clearance and maintenance
• Previous experience of leading a team to prepare for and attend major health authority interactions (e.g., pre-IND meeting, EOP1, EOP2 meetings, etc.)
• Experience in regulatory submission project management
• Previous experience in the preparation and submission of a BLA is a plus
• PharmD or PhD in a scientific discipline.
• Regulatory Affairs certification is a plus
• Strong attention to detail, translating into the ability to produce high-quality regulatory documents.
• Ability to establish and maintain a positive, strong and efficient collaborative working relationship within the Regulatory team and with other functions and stakeholders
• Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes.
• Ability to develop partnerships that support a strong cross-functional and inclusive team environment
• Ability to work in autonomy on allocated program(s)
• Excellent organizational, computer and documentation skills.
• Solution-oriented approach to problem-solving including assessing variables, evaluating fundamental issues, anticipating business impact and providing direction.
• General interest in a broad range of Regulatory activities.
• Strong interpersonal skills including verbal and written communication.