Director, Global Regulatory Affairs

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.

• 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%

• 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.

Job Type: Full-time

Benefits:

·             Annual bonus program

·             Incentive stock option plan

·             401k plan with flat non-elective employer contribution

·             Comprehensive medical insurance with 90-100% employer-paid premiums

·             Dental and vision insurance

·             HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)

·             Unlimited PTO

·             Generous holiday schedule; includes summer and winter company shutdown

·             Relocation assistance

Schedule:

·             Monday to Friday

Work authorization:

·             United States (Required)

Additional Compensation:

·             Annual targeted bonus %

Work Location:

·             Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required.

EQUAL OPPORTUNITY EMPLOYER:

Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.