Cardiovascular is committed to adhering to ethical and regulatory standards while fostering a culture of integrity and collaboration.
About the Role
The Clinical Regulatory Associate Director will be responsible for ensuring compliance with regulatory standards and facilitating the approval process for innovative drugs in designated therapeutic areas.
Responsibilities
- Adherence to Ethical and Regulatory Standards
- Align with company values and vision.
- Ensure regulatory affairs comply with regulatory regulations and company guidelines.
- Protect company confidential information (intellectual property, product information, and strategic data).
- Disclose any potential violations of ethical standards.
- Regulatory Planning and Execution for Innovative Drugs in Therapeutic Areas
- Participate in the discussion and formulation of regulatory strategies for innovative drugs in designated therapeutic areas, aligned with corporate strategy and leadership directives. Develop and implement annual regulatory plans for products in the therapeutic area, based on project initiation and R&D plans.
- Manage critical project milestones to ensure timely submission of regulatory projects. Monitor and accelerate the approval process for filed products.
- Coordinate and supervise cross-functional teams in preparing regulatory documents (e.g., marketing authorization applications, clinical trial applications, supplement applications), ensuring timely compilation and submission.
- Organize and oversee the preparation of documents for communication requests, breakthrough therapy designations, priority review applications, etc., ensuring timely submission.
- Review and analyze the compliance of research and submission materials, identify discrepancies with regulatory requirements, and request supplements/revisions to meet standards.
- Track evaluation progress, coordinate responses to regulatory queries, inspections, and testing to ensure timely provision of required materials.
- Guide regulatory personnel in product lifecycle maintenance per regulations and company SOPs.
- Collaboration with Regulatory Agencies for Compliance and Accelerated Approval
- Deeply understand regulatory guidelines and maintain effective communication with regulatory bodies.
- Collaborate with project teams to proactively engage regulators, leveraging drug characteristics to optimize strategies and accelerate approvals, within compliance frameworks.
- Utilize company resources to strengthen relationships with regulators and enhance corporate reputation.
- Monitor regulatory updates and environmental changes.
- Internal Regulatory Support
- Provide regulatory/strategy advice to internal teams based on product knowledge and regulatory expertise.
- Foster collaboration with internal teams to deliver timely regulatory support for project and cross-functional teams.
- Support external partnerships by facilitating communication between internal teams and external partners.
- Track and analyze regulatory policies/clinical guidelines, share updates with relevant departments, collect feedback on draft guidelines, and organize internal discussions/training.
- Team Management and Collaboration
- Mentor and develop talent, leading teams in adherence to core values and fostering growth.
- Share industry insights and expertise to promote effective communication and a positive team culture.
- Facilitate knowledge-sharing of project lessons to enhance team capabilities and efficiency.
- Support team development with innovative, constructive proposals.
Qualifications
- Education:
Bachelor's degree or higher in pharmacy, medicine, or related fields. - Experience:
Minimum 10 years of regulatory experience in pharmaceutical companies; minimum 8 years in regulatory affairs. - Language:
Proficiency in written and spoken English.
Required Skills
- Proven track record of integrity and ethics, with strong credentials from major pharmaceutical companies.
- In-depth knowledge of China's regulatory landscape, guidelines, and effective communication with regulators.
- Proficiency in office software, interpersonal communication, and teamwork.