The Head of Regulatory Affairs is a leadership position responsible for the strategic oversight of all regulatory affairs activities related to the development, and registration of company products. This role is critical for establishing effective regulatory strategies across ModeX programs and for ensuring compliance with applicable regulations and guidelines set forth by regulatory authorities such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Key accountability and responsibilities include providing regulatory strategic input to the non-clinical and clinical development programs; leading the preparation of regulatory submissions and interactions with regulatory agencies; collaborating with clinical, program management, CMC, and nonclinical teams and company executives.
Key Responsibilities
- Regulatory strategy development: Develop and execute regulatory strategies for product development, particularly non-clinical and clinical development, taking into account regional and global regulatory requirements. Provide strategic input and guidance to cross-functional teams to ensure regulatory compliance.
- Regulatory submissions: Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and other relevant submissions. Ensure submissions are accurate, complete, and in compliance with regulatory guidelines.
- Compliance and regulatory intelligence: Monitor and interpret changes in regulations, guidelines, and legislation that may impact the company's products and operations. Stay up to date with current regulatory requirements and industry best practices. Provide advice and guidance on compliance issues and potential risks. Participate in relevant conferences, seminars, and workshops.
- Interactions with regulatory authorities: Serve as the primary point of contact for regulatory agencies. Represent the company in meetings, discussions, and negotiations with regulatory authorities. Prepare and present regulatory strategies, data, and responses to regulatory queries.
- Cross-functional collaboration: Collaborate with and provide guidance to cross-functional teams including research, development, clinical operations, quality assurance, and CMC teams to ensure regulatory requirements are integrated into development plans, clinical trials, manufacturing processes, and labeling. Build effective collaborations with OPKO regulatory affairs.
- Regulatory compliance: Ensure compliance with applicable regulations, standards, and guidelines throughout the product development. Develop and maintain standard operating procedures (SOPs) and regulatory policies; conduct internal audits and assist with regulatory inspections and audits from regulatory authorities, in collaboration with OPKO regulatory affairs and quality organization.
- Risk assessment and mitigation: Identify and assess regulatory risks and propose appropriate mitigation strategies. Provide regulatory input to risk management activities, including risk assessments and risk mitigation plans.
Qualifications
- Advanced degree (M.S. Ph.D., M.D., or equivalent) in a relevant scientific discipline.
- Extensive experience (12+ years) in the biotech or pharmaceutical industry, with a focus on non-clinical and clinical development, required for immuno-oncology, preferred for infectious diseases.
- Strong knowledge of preclinical research, pharmacology, toxicology, and clinical development processes.
- Demonstrated leadership and collaboration experiences in multidisciplinary teams and cross-functional projects.
- In-depth understanding of regulatory requirements and guidelines for IND submissions and early clinical trials.
- Excellent communication and presentation skills, with the ability to effectively convey scientific concepts and development strategies to both technical and non-technical audiences.
- Collaborative mindset and the ability to build and maintain relationships with internal and external stakeholders.
ModeX Therapeutics is an Equal Opportunity Employer