Posted 5 months ago

Director, Global Regulatory Affairs

San DiegoOn-siteFull-time

AI Summary

The Director, Global Regulatory Affairs leads the development and execution of global regulatory strategies for clinical programs, owns submission preparation and agency interactions, and serves as the primary regulatory lead across health authorities and cross-functional teams.

About this role

The Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support the global development and expansion of Janux’s clinical pipeline. This player-coach individual will work closely with cross-functional teams to ensure compliance with regulatory requirements and to achieve successful regulatory approvals.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Develop and execute global regulatory strategies for one or more programs.

Will be the regulatory lead for project teams and sub-teams for one or more programs.

Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc.).

Serve as the primary regulatory contact with health authorities, including the FDA, EMA, MHRA and other global regulatory agencies for assigned programs.

Provide regulatory guidance and support to cross-functional teams, including Clinical, Therapeutic Discovery, and CMC teams.

Monitor and interpret regulatory requirements and trends to ensure compliance and to inform strategic planning.

Manage regulatory timelines and ensure timely submission of regulatory documents.

Lead regulatory agency meetings and negotiations.

Own the preparation of regulatory documents, including briefing packages, responses to health authority queries, and labeling.

Ensure that all regulatory activities are conducted in accordance with applicable regulations, guidelines, and company policies.

Other duties as deemed necessary.

Travel up to 25%

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

BS degree in life sciences or a related field is required. Advanced degree in life sciences (MS, PhD, PharmD, MD, or equivalent) preferred.

Minimum of 10 years of experience in regulatory affairs within the biotechnology and biopharmaceutical industries and working knowledge of the development of biologics targeted for the treatment of cancer.

Proven track record of successful regulatory submissions and approvals, alongside successful direct interaction with global regulatory agencies (FDA, EMA MHRA and others).

In-depth knowledge of global regulatory requirements and guidelines is required.

Strong leadership and project management skills.

Excellent written and verbal communication skills.

Ability to work effectively in a fast-paced, dynamic environment.

Strong analytical and problem-solving abilities.

Ability to build and maintain effective working relationships with internal and external stakeholders.

Skills

Biologics DevelopmentBLAsEMAFDAGlobal Regulatory GuidelinesINDsMaaSMHRANDAsRegulatory Affairs

Director, Global Regulatory Affairs

About this role

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

Skills

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