Global Director of Regulatory Affairs

ORGANIZATION RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland.

By leveraging our deep insights into oncology and immunology, advanced protein engineering / design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs.

RemeGen Biosciences is a wholly owned subsidiary of RemeGen Co., Ltd a global pharmaceutical company specialized in autoimmune, oncology and ophthalmic diseases.

POSITION SUMMARY The Director of Global Regulatory Affairs will serve as a pivotal member of the organization, overseeing regulatory strategies and operations, particularly for product registrations and indications in international markets, with a focus on the US, EU, Australia, and China.

This role will be the local regulatory lead and internal expert for the Autoimmune Clinical Development team, providing regulatory guidance to cross-functional project teams, ensuring compliance with international regulations, assessing regulatory risks, and engaging with health authorities.

With a strong scientific and technical background in large molecular drug-development, the Director will strategically manage interactions with regulatory agencies, optimize project submissions, and maintain vigilant awareness of evolving regulatory landscapes.

This is a remote position for candidates located in Massachusetts, Pennsylvania, South Carolina, and Texas.

KEY RESPONSIBILITIES   As local regulatory lead, represent Regulatory Affairs (RA) in assigned project meetings and provide regulatory guidance as appropriate, and for preparation of regulatory documents.

Serve as an internal expert in International RA by providing strategic and operational guidance to management and project teams for the international registration of new products or new indications, especially for the US, EU, and Australia, including :

• Providing interpretation regarding regulations and advice on interactions with agencies (FDA, EU, etc.) and their guidance requirements.
• Monitor and anticipate changes in regulatory and access environments that might impact company portfolio programs and provide timely advice to management and project teams.
• Identify and assess regulatory risks, mitigations, and contingencies.
• Support China product RA lead or indication RA lead to prepare and review meeting requests and briefing documents; responsible for submission and follow up with the review and responses to requests from regulatory agencies.
• Work with RemeGen China product RA lead or indication RA lead to plan, prepare, and review submissions to regulatory agencies, to support RA submission approval.
• Ensure all documents and communications with regulatory agencies are timely, accurate, complete, verifiable, and in compliance with agencies’ requirements.
• Responsible for organizing FDA communication meetings to ensure meeting quality.
• Responsible for managing CRO depending on project assignment.
• Responsible for the preparation, review, and submission of ODD documents in the U.S. and Europe.
• Liaison with health authorities as needed.
• Archive management for related projects, sending to China’s central archiving.

REQUIREMENTS   Education :

Experience :

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OTHER   Supervisory Responsibilities :

BENEFITS   Benefits :