Senior Director, Global Regulatory Affairs

Janux Therapeutics; California (MO); On-site; USD 228,000 - 245,000; Full time

Benefits offered by this job

Annual bonus program

Incentive stock option plan

401k plan with employer contribution

Comprehensive medical insurance

Unlimited PTO

Generous holiday schedule

Job summary

A biotechnology company in Missouri is seeking a Director of Global Regulatory Affairs responsible for developing and executing regulatory strategies supporting its clinical pipeline. This leadership role involves working with cross-functional teams to ensure compliance and successful regulatory approvals with agencies like the FDA and EMA. Candidates should have at least 10 years in regulatory affairs and a strong track record of submissions. The position offers a competitive salary of $228,000 to $245,000 annually, alongside stock options and comprehensive benefits.

Qualifications

• Minimum of 10 years of experience in regulatory affairs in biotech.
• Proven track record of successful regulatory submissions.
• In-depth knowledge of global regulatory requirements.

Responsibilities

• Develop and execute global regulatory strategies.
• Serve as primary regulatory contact with health authorities.
• Lead preparation and submission of regulatory filings.

Skills

Leadership

Project management

Regulatory compliance

Analytical skills

Communication

Education

BS degree in life sciences

Advanced degree (MS, PhD, PharmD, MD)

Job description

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.
• 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.

$228,000 - $245,000 a year

In addition to a competitive base salary ranging from $228,000 to $245,000, 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.

Please note that 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

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.