|Job Description||Associate Director, Regulatory Affairs|
What is this role really like?
Mirati is looking for a talented Associate Director, Regulatory Affairs to join our growing team! Reporting to the Head of Regulatory Affairs, the Associate Director, Regulatory Affairs provides key support to the Regulatory Affairs department. This position has primary responsibility for coordination and assembly of regulatory documents for review and submission to health authorities (primarily the FDA, other regulatory agencies as needed) and assists GRLs with strategies and submissions as appropriate. The Associate Director, Regulatory Affairs will be responsible for maintaining and updating archival copies of health authority submissions (e.g. IND, BLA, and MAA). The Associate Director, Regulatory Affairs will ideally have a working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs.
The primary job functions include but are not limited to the following:
- Under the direction of a senior Regulatory staff member, prepare, compile review, and submit documents for the company, including but not limited to initial INDs/CTAs/BLAs and amendments or supplements.
- Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
- Develop, maintain, and communicate timelines for regulatory submissions.
- Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
- Coordinate with Regulatory Operations to gather and assemble information necessary for submissions to health authorities in accordance with regulations and guidelines.
- Maintain databases of regulatory information, submissions and correspondence.
- Follow general instructions to complete projects while independently planning daily work to complete time sensitive assignments.
- Review, write, and present guidelines and SOPs as needed to support high quality submissions and assure adherence to regulatory requirements.
- Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration
What would a successful candidate look like?
- A minimum of a BS in life sciences with at least 8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience may be considered).
- Understanding of the drug development process and knowledge of global guidance and regulations.
- Has successfully supported health authority submissions and critical projects while maintaining agreed timelines.
- Previous experience with IND filings or maintenance required and previous experience with eCTD formatted submissions and NDA or BLA filings desirable
- Excellent oral and written communication skills.
- Time management skills are essential.
- Demonstrated ability to work effectively with cross-functional teams e.g. research, clinical, and CMC teams.
- Ability to implement regulatory plans and strategies and proactively identify risks.
- Ability to work on multiple tasks to meet company objectives.
- Strong attention to detail.
- Knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
- Excellent Computer Skills – MS Word, Excel, Power Point, and document management software/system.
- Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus
- Previous experience with maintaining in house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (eg, Veeva) is a plus