Reporting to the Senior Director of Regulatory Affairs and CMC, the Director will:
Actively lead development and implementation of regulatory strategies for assigned programs and ensure cross functional alignment.
Lead regulatory activities (nonclinical, clinical and CMC) to assure timelines and milestones.
Interface with Commercial Regulatory Affairs developing GRASP’s.
With support of Commercial RA, develop initial product labeling and assess proposed product claim proposal (pre-NDA).
Interface with Business Development conducting due diligence and assessing commercial viability of potential drugs.
Provides Regulatory Risk Assessment (RRA) during various phases of product development.
Monitor current and proposed regulatory and legal issues, and ensure that key initiatives are communicated to the stakeholders.
Coordinate all aspects of regulatory submissions relevant to assigned programs, including coordinating regulatory workflow, reviewing technical documents (nonclinical, clinical, and CMC), developing and tracking submission timelines, and supervising preparation of regulatory submissions to ensure compliance with regulations and guidelines. It is expected that the Director will also have some experience outside the US.
Review and approve protocols, reports, and documents used in regulatory submissions.
Prepare IMPD to support international CTA submissions.
Lead as a key member of Global Regulatory Project Teams.
Lead multidisciplinary team responding to Health Authority questions during the IND and NDA review phases for assigned projects.
Act as liaison between Regulatory Affairs and other functional areas, including external contractors (e.g., contract research organization teams and vendors).
Support Quality Assurance activities during pre-approval GCP and GMP FDA/EMEA/PMDA inspections.
Work with development partners as required; assist in due diligence activities.
Expand and precede the organization's policies and procedures for regulatory affairs and compliance to establish a compliant culture.
Maintain knowledge and monitor changes in pertinent laws, regulations and guidance. Interpret external developments and inform/educate internal stakeholders.
Identify the need for new regulatory policies, processes and SOPs, approve and ensures implementation.
Works closely with Regulatory Operations to ensure e-CTD compliance.