This is a fantastic opportunity to become part of a premier biologics center of excellence, committed to developing and providing transformative medicines to patients. The company I'm working with is focused on empowering innovative teams with state-of-the-art technologies to design groundbreaking therapies that tackle critical health challenges. As the Senior Director of Regulatory Affairs, you will lead the Regulatory team. The Senior Director will over see that all clinical, CMC and nonclinical regulatory requirements are met.
RESPONSIBILITIES:
- Developing and executing global regulatory strategies for preclinical and early clinical development programs.
- Working closely with the late-phase regulatory team at an external partner to ensure seamless global regulatory compliance and a smooth transition into later stages of development.
- Establishing the late-phase regulatory framework to facilitate a successful biologics license application (BLA) submission.
- Overseeing the timely preparation, review, publication, and submission of regulatory documents to global health authorities (e.g., FDA, EMA, PMDA), including:
- IND/CTA/CTN submissions (including scientific rationale, investigator brochures, and other essential documents).
- Cross-functional regulatory documents (e.g., protocols, amendments, DSURs, informed consent forms, and exploratory analysis reports).
- Developing pre-IND strategies, determining optimal timing and communication approaches, and coordinating Health Authority interactions, including preparing briefing materials and meetings.
- Identifying and mitigating potential regulatory risks to strategic and operational plans, communicating risk management strategies to internal and external stakeholders, senior leadership, and key partners.
- Developing phase-appropriate regulatory strategies for Chemistry, Manufacturing, and Controls (CMC).
- Providing regulatory oversight for change control documentation and associated cGMP compliance documentation.
- Identifying and addressing regulatory risks related to CMC strategies and operational plans.
- Ensuring that CMC processes and workflows are aligned with Health Agency requirements, including preparation of briefing documents and responses to queries.
- Managing CMC-related regulatory submissions (e.g., original INDs, CMC amendments, IMPD amendments, annual reports, agency meeting requests, briefing materials, and marketing applications).
QUALIFICATIONS:
- B.S. or MSc degree in a scientific discipline is required, with 10-12+ years of experience in US Regulatory Affairs within the biotechnology or pharmaceutical industry.
- Broad experience managing submissions across various regulatory domains (CMC, Clinical, Nonclinical), with a preference for biologics expertise.
- Strong background in regulatory strategy development and regulatory writing.
- Experience in immunology and/or nephrology regulatory affairs is a plus.
- High attention to detail with the ability to interpret complex information and communicate effectively through written, oral, and presentation skills.
- Demonstrated ability to collaborate effectively with internal teams and external partners, building and maintaining strong professional relationships.
