Associate Director, Global Regulatory Affairs

The Associate 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 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.
• 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.
• Participate in regulatory agency meetings and negotiations.
• Oversee 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.

• 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 8 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:

·         401K

·         Medical insurance

·         Dental insurance

·         Vision insurance

·         Supplemental disability insurance plans

·         Flexible schedule

·         Life insurance

·         Flexible vacation

·         Sick time

·         Incentive stock option plan

·         Relocation assistance

Schedule:

·         Monday to Friday

Work authorization:

·         United States (Required)

Additional Compensation:

·         Annual targeted bonus X%

Work Location:

·         On site (San Diego, CA)

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.

Notice to Recruiters and Third-Party Agencies

The Talent Acquisition team manages the recruitment and employment process for Janux. To protect the interests of all parties involved, Janux will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Janux employees directly in an attempt to present candidates. Janux will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.

Salary : $175,000 - $188,000