Senior Director, Global Regulatory Affairs

Overview

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.

Responsibilities

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


• 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.

Compensation and Benefits

Salary: $228,000 - $245,000 a year

In addition to a competitive base salary, we offer stock options, restricted stock units, a stock purchase plan (ESPP) and a target bonus. Janux also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance. Relocation assistance may also be available. The base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, internal equity, and work location.

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

Work Schedule

Schedule: Monday to Friday

Work Authorization

Work authorization: United States (Required)

Location

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

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.