Director/Sr Director, Regulatory Affairs

PRIMARY RESPONSIBILITIES

The Director / Senior Director, Regulatory Affairs is responsible for :

• Developing and executing the global regulatory strategy for preclinical and early clinical development assets.
• Interfacing and aligning with the late phase regulatory unit at Otsuka to ensure global regulatory compliance, continuity through transition to late phase activities, and to set up Otsuka late phase regulatory unit for smooth, successful BLA submission, including strategy for :
• Surrogate and approval endpoints, and clinical outcome assessments.
• Special status designations such as orphan drug, fast track and breakthrough designation.
• Overseeing the timely preparation, review, publishing, and submission of documents to Global Health Authorities (FDA, EMA, PMDA etc.), including but not limited to :
• IND / CTA / CTN packages including Scientific Rationale, IB, ISI etc.
• Cross-functional documents including protocols & amendments, DSURs, ICF and exploratory / MoA analyses.
• Developing pre-IND strategy with respect to timing, type of communications. Accountable for coordinating Health Authority interactions, including leading team through creation of briefing materials and meeting preparation and serving as the key contact for Regulatory interactions.
• Ensuring compliance with applicable regulatory requirements and best industry practices and informing the company of any changes to requirements and procedures
• Proactively identifying potential regulatory risks to the strategic / operational plans of Visterra assets, proposing options to mitigate risk, and communicating with internal and external team members, senior leaders, and key stakeholders on the status of, risks and mitigation plans associated with the regulatory milestones.
• Oversee Registry entries (CT.gov etc.), redactions etc.
• Regulatory CMC activities :
• Phase appropriate CMC-regulatory strategy
• Provide regulatory oversight for change control documentation and related cGMP documentation
• Identify regulatory risks to the CMC strategic / operational plans
• Ensure CMC process / workflows are in place related to Health Agency interactions (i.e., briefing documents and responses to questions)
• CMC regulatory submissions (e.g., original INDs, CMC amendments, IMPD Amendment, annual reports, Agency meeting requests, meeting briefing packages, marketing applications) appropriate to the stage of product development.
• Support :
• CMC functions (e.g. Process Development, Analytical Development, Manufacturing and Quality Control) on the preparation and content of CTA / IMPDs, PPQs, INDs dossiers to ensure timely delivery of final documents to be included in submissions.
• Support best practice for regulatory CMC compliance activities including, but not limited to, change controls.

Additional activities :

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

LEADERSHIP CHARACTERISTICS