Director, Global Regulatory Affairs
Janux Therapeutics
7 hours ago
Remote friendly (San Diego County, CA)
United States
$228,000 - $245,000 USD yearly
Corporate Functions
Essential Functions and Responsibilities:
- Develop and execute global regulatory strategies for one or more programs.
- Serve as regulatory lead for project teams and sub-teams for one or more programs.
- Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc.).
- Act as primary regulatory contact with health authorities (FDA, EMA, MHRA, and other global agencies) for assigned programs.
- Provide regulatory guidance and support to cross-functional teams, including Clinical, Therapeutic Discovery, and CMC.
- Monitor and interpret regulatory requirements and trends to ensure compliance and inform strategic planning.
- Manage regulatory timelines and ensure timely submission of regulatory documents.
- Lead regulatory agency meetings and negotiations.
- Own preparation of regulatory documents, including briefing packages, responses to health authority queries, and labeling.
- Ensure 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 related field required; MS/PhD/PharmD/MD or equivalent preferred.
- Minimum 10 years of regulatory affairs experience in biotechnology/biopharmaceutical industries; working knowledge of biologics for cancer.
- Proven track record of successful regulatory submissions and approvals; direct interaction with global agencies (FDA, EMA, MHRA, others).
- In-depth knowledge of global regulatory requirements and guidelines.
- Strong leadership and project management skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced environment.
- Strong analytical and problem-solving abilities.
- Ability to build and maintain effective relationships with internal and external stakeholders.
Benefits:
- Annual bonus program; incentive stock option plan; 401k with flat non-elective employer contribution
- Medical (90–100% employer-paid premiums), dental, vision
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Unlimited PTO; generous holiday schedule (summer and winter shutdown)
- Relocation assistance may be available.
- Develop and execute global regulatory strategies for one or more programs.
- Serve as regulatory lead for project teams and sub-teams for one or more programs.
- Lead preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc.).
- Act as primary regulatory contact with health authorities (FDA, EMA, MHRA, and other global agencies) for assigned programs.
- Provide regulatory guidance and support to cross-functional teams, including Clinical, Therapeutic Discovery, and CMC.
- Monitor and interpret regulatory requirements and trends to ensure compliance and inform strategic planning.
- Manage regulatory timelines and ensure timely submission of regulatory documents.
- Lead regulatory agency meetings and negotiations.
- Own preparation of regulatory documents, including briefing packages, responses to health authority queries, and labeling.
- Ensure 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 related field required; MS/PhD/PharmD/MD or equivalent preferred.
- Minimum 10 years of regulatory affairs experience in biotechnology/biopharmaceutical industries; working knowledge of biologics for cancer.
- Proven track record of successful regulatory submissions and approvals; direct interaction with global agencies (FDA, EMA, MHRA, others).
- In-depth knowledge of global regulatory requirements and guidelines.
- Strong leadership and project management skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced environment.
- Strong analytical and problem-solving abilities.
- Ability to build and maintain effective relationships with internal and external stakeholders.
Benefits:
- Annual bonus program; incentive stock option plan; 401k with flat non-elective employer contribution
- Medical (90–100% employer-paid premiums), dental, vision
- HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
- Unlimited PTO; generous holiday schedule (summer and winter shutdown)
- Relocation assistance may be available.