The Director, or Senior Director of Regulatory Sciences and Affairs is a senior-level position responsible for overseeing and managing all aspects of regulatory affairs activities related to the development, and registration of company products. This role is critical 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 design and hands-on execution of non-clinical and clinical development programs; leading the preparation of regulatory submissions and interactions with regulatory agencies; collaborating with clinical, project planning and management, and company executives to develop regulatory strategy, submission/briefing dossiers, and conduct consultations with regulatory agencies.
More Specific Accountabilities and 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 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.
- 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.
- Team Management: Build and lead a team of regulatory affairs professionals. Provide guidance, mentorship to team members. Foster a culture of regulatory compliance and excellence. Build effective collaborations with OPKO Regulatory Affairs.
- 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 and Requirements:
- Advanced degree (M.S. Ph.D., M.D., or equivalent) in a relevant scientific discipline.
- Extensive experience (typically 10+ years, 12+ years for senior director) in the biotech or pharmaceutical industry, with a focus on non-clinical and clinical development, particularly in the areas of immuno-oncology and 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.
About ModeX Therapeutics, Inc.
ModeX Therapeutics, a subsidiary of OPKO Health Company, is a biotech company based in Massachusetts dedicated to the concept of modulating multiple disease targets with an innovative multi-targeting approach. It was founded by Dr. Elias Zerhouni and Dr. Gary J. Nabel with a team of established and dedicated scientists in 2020 and is pursuing the development of novel immune-oncology therapeutics for cancers and infectious disease.
ModeX Therapeutics is an Equal Opportunity Employer