The Associate Director, Regulatory Affairs, plays a pivotal role in coordinating and leading regulatory strategies for SillaJen's clinical development programs. This individual will collaborate with various internal teams, ensuring alignment with global regulatory requirements and standards. They will also serve as a primary point of contact for regulatory agencies and corporate partner programs, ensuring timely and effective communication.
Essential Duties and Responsibilities
- Strategic Leadership: Formulate and drive global regulatory strategies for SillaJen's pre-clinical and clinical programs, aligning with the company's broader objectives and ensuring regulatory compliance.
- Documentation & Submission: Lead the preparation, coordination, and submission of comprehensive regulatory documentation, ensuring accuracy and adherence to regulatory standards.
- Cross-functional Collaboration: Act as the regulatory voice in cross-functional teams, integrating regulatory considerations into project plans, strategies, and decision-making processes.
- Regulatory Agency Interaction: Build and maintain strong relationships with the FDA and other global regulatory authorities, facilitating open communication and prompt response to regulatory inquiries.
- Regulatory Intelligence: Continuously monitor and analyze evolving regulatory guidelines, ensuring the organization remains compliant and is informed of relevant changes.
- Cross-Functional Leadership: Act as a mentor and guide for cross-functional teams, fostering a culture of collaboration and ensuring alignment with regulatory objectives.
- Risk Management: Proactively identify potential regulatory risks, develop mitigation strategies, and ensure the smooth progression of development programs.
- Consultant Collaboration: Collaborate effectively with external Regulatory consultants, ensuring seamless integration and alignment with the company's regulatory objectives.
- Meeting Coordination: Organize and lead regulatory meetings, ensuring thorough preparation, including the development of briefing documents and conduct of rehearsals.
Regulatory Guidance: Provide clear regulatory guidance to project teams, keeping them informed of regulatory requirements, potential changes, and overall regulatory landscape
Education and Experience
- Educational Background: Degree in biological or life sciences, pharmacy, or medicine. An advanced degree is a plus.
- Experience: Minimum of 8 years in Regulatory Affairs with a focus on clinical development. Demonstrated experience in strategic problem-solving with health agencies and a proven track record of successful regulatory submissions. Significant experience in global clinical trials and their regulatory requirements is essential.
- Regulatory Knowledge: Comprehensive understanding of FDA regulations, with experience in EU and other international regulations. Familiarity with the latest eCTD format and evolving FDA, ICH, and other relevant regulations and guidelines.
- Communication Skills: Exceptional oral and written communication skills, with the ability to articulate complex regulatory challenges and provide clear guidance to internal teams.
- Team Collaboration: Proven experience in working collaboratively across various departments, fostering a cohesive approach to regulatory challenges.
- Autonomy: Capable of working efficiently with minimal supervision, demonstrating self-motivation and initiative.
- Specialized Experience: Prior experience in biologics and/or oncology drug development is highly desirable.
- Clinical Trials Expertise: Demonstrated knowledge and hands-on experience related to the planning and execution of clinical trials.
- Health Agency Interaction: Experience in direct communication and collaboration with health agency representatives, whether through a Program/Project Manager or directly with agency reviewers.
- Communication Skills: Ability to clearly articulate regulatory challenges, propose potential solutions, and provide well-informed recommendations for decision-making. This includes effective communication through emails, team presentations, and other mediums.
- Technical Proficiency: Skilled in using MS Word, PowerPoint, and Project. Familiarity with Adobe Acrobat Professional is beneficial, and experience with electronic publishing systems is a plus.
SillaJen Biotherapeutics, Inc will consider for employment qualified applicants consistent with the requirements of the San Francisco Fair Chance Ordinance.
Equal Opportunity & Inclusive Workplace
SillaJen Biotherapeutics, Inc is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, national origin, sexual orientation, gender identity or expression, religion, age, pregnancy, disability, work-related injury, covered veteran status, political ideology, marital status, or any other factor that the law protects from employment discrimination. Our team and our office aims to be an accessible and hospitable place to work. We welcome applicants, contractors, and employees who are committed to improving our culture and practices.