Reporting to the CMO, the Director of Regulatory Affairs manages, reviews, plans and prepares complex regulatory submission documents for FDA and global filings. The Director drives regulatory strategy, advising on CMC, non-clinical, and clinical development programs.
Grow and manage regulatory department
- Create and implement fine-tuned regulatory strategy to advance the development of biologics including Pre-IND through approval, and life-cycle management.
- Author regulatory documents in support of filing including INDs/CTA, first in human trials, phase 1 trial design
- Lead all global biologic CMC/Pharm-Tox regulatory submissions including coordination, authoring, development and submission.
- Define and document risks and key regulatory CMC issues related to the pre-clinical and clinical development and manufacturing of product.
- Develop and maintain the regulatory filing calendar and works with cross-functional stakeholders across the organization
- Expert knowledge of FDA regulations including regulations and policies related to biological products.
- Initiate and lead Health Authority interactions and negotiations including setting objectives, preparing briefing books, rehearsals, risk mitigation and meeting coordination.
- Plan, manage, and execute regulatory activities including submission and maintenance of global regulatory filings to meet strict deadlines
- Provide strategic regulatory advice to project team as required
- Remain current on Regulatory Intelligence including new guidance documents and competitive information to properly inform decisions and internal team
- Support or lead other activities as needed including SOP development and organizational initiatives for regulatory compliance
Serve as the liaison between the Company and the FDA/international regulatory bodies in product submission/registration/licensing
- Ensure appropriate labeling for IP
- Ensure global regulatory compliance standards are met
- Build and manage the regulatory department to support product development
- Establish global strategic consistency across regulatory submissions
- Excellent verbal, written, presentation and interpersonal communication skills.
- Excellent organizational skills and attention to detail.
- Ability to multitask, prioritize, and manage time effectively. Strong problem-solving skills
- Experience with MABEL dosing and bispecific T-cell engaging antibodies a plus
EDUCATION AND EXPERIENCE
- Bachelor’s degree in science (e.g., Chemistry, Pharmacy, Biochemistry, Biology) or equivalent. Advanced degree preferred.
- Minimum 7-10 years of regulatory/biotech or health science industry experience
- Previous experience and expertise interacting with FDA and CDER for biologics (preferred)
- Demonstrated technical leadership in the successful submissions to regulatory agencies of INDs in CTD format, IMPDs, CTAs, NDA, Period Safety Update Reports, etc.
- Proven experience in all components of regulatory submissions including Chemistry, Manufacturing, non-clinical and clinical documentation
- Knowledge of FDA and/or EMA/TGA regulations, ICH guidelines and GCP.
- Demonstrated experience in applying regulatory CMC knowledge to various situations
- Knowledge and experience with Windows, MS Office (Outlook, Word, PowerPoint, Excel) and SharePoint
- Experience using business intelligence tools and data frameworks.
- Travel may be required up to 15%
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
We provide competitive compensation, bonuses, equity program, and health and welfare benefits, including medical, dental, vision, life insurance, 401K, and EAP.
AN 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.