Cong Shen

- Strategic Planning: Developed global regulatory and submission strategies aligned with overall corporate objectives, ensuring seamless domestic and international drug registration approvals across key markets. - System Development: Established and streamlined regulatory and submission system, developed 10 SOPs and workflow standards, and created 7 major categories of regulatory document templates, including clinical trial applications for China and the US, orphan drug designations for the US and EU, and FDA/EMA meeting packages, significantly improving efficiency and compliance. - Team Management: Managed a cross-functional submission team, responsible for team building and talent development, and guided team members in completing clinical trial application submissions and document preparation to simultaneously submit clinical trial applications in China and the US. - Regulatory Success： Led the submission of 2 US FDA INDs, 1 China IND approval, and 10 orphan drug designations (US FDA and EMA) within 15 months. - Regulatory Agency Engagement： Led over 10 regulatory meetings with the US FDA (Pre-IND and Type C), China CDE (Type 1-3), CDE Yangtze River Delta Center on-site meetings, and EU EMA (orphan drug designation discussions), ensuring the achievement of corporate goals and project strategies. - Cross-functional Collaboration： Worked closely with CMC, medical, and clinical teams to align regulatory strategies with overall corporate goals. - Team Leadership: Managed a regulatory team (including external RA CROs) to promote efficient project execution, evaluating clinical trial applications and CRO selections to ensure high-quality submissions across multiple regions.

Global regulatory affairs strategy development for startup biotech company involved in gene therapy.

- Regulatory Leadership: Established and improved the registration and submission system, developed global registration strategy and implementation plans, and provided solutions for registration-related issues, ensuring high-efficiency delivery of tasks. - Team Management: Managed a 5-member RA team, overseeing the global Conbercept Phase 3 clinical trial RA activities. - Pipeline Development: Led regulatory strategy for next-generation ophthalmic gene therapy KH631 and the international RA activities for the ocular treatment KH906, ensuring high-quality deliverables. - Regulatory Template Development: Designed and implemented regulatory submission templates for INDs, FDA Special Protocol Assessment (SPA), Risk Evaluation and Mitigation Strategies (REMS), FDA communication package, and safety reports, significantly improving efficiency and compliance. - Multi-functional Collaboration： Coordinated with clinical operations, CMC, medical, and GMP teams to respond to regulatory inquiries promptly, ensuring smooth project progress. Coordinated cross-departmental preparation and review of IND annual reports, IB, and IMPD. - Global Regulatory Engagement： Led 30+ global regulatory meetings (US FDA Pre-IND, FDA communication meetings, EMA scientific advice, and Japan PMDA consultation), fostering strong interactions with regulatory authorities. - CRO Management： Supervised CRO bidding, contract negotiations, change order management, and global investigator meetings. Developed bid evaluation, research budget planning, and risk management plan. - Consultant Management： Led a 10-member consultant team (including steering committee members and clinical physicians), providing scientific and project background to ensure high-quality scientific and regulatory guidance.

- Regulatory Affairs： Led the preparation, review, and submission of registration dossiers, ensuring compliance with US FDA and ICH guidelines and facilitating smooth project approvals. - Clinical Project Management： Managed the US Phase 3 clinical trial of Conbercept, developing high-priority project plans and overseeing timelines, budgets, and execution. Supported China's first Phase 0 clinical trial (FP3 protein for primary liver cancer), supporting project design, implementation, and data analysis. - CRO Oversight： Designed and implemented a CRO evaluation scoring system, optimizing partner selection processes to ensure clinical research quality and efficiency. - Regulatory Compliance： Conducted GLP site inspections and reviewed preclinical reports to ensure compliance with regulatory standards. - Innovation Management： Managed a meta-analysis project on traditional Chinese medicine (Shugan Jiedu Capsule) for depression, from literature research to data analysis. - Due Diligence： Conducted due diligence on target products from a registration perspective, assessing compliance and market potential to support corporate strategic decisions.

- Client Development: Developed potential client relationships across universities, hospitals, and research institutes through phone calls and visits, established and maintained potential client lists, and drove business growth. - Event Organization: Led business activities in the BENELUX and German regions to promote core products and enhance brand awareness and market share. - Contract Negotiation：Designed and implemented negotiation strategies, participated in contract negotiations, and managed the full lifecycle of contract execution to ensure timely project delivery.