Job description
We are looking for a Senior Director of Regulatory Affairs with a proven track record in the development of drugs, biologics/vaccines, and also in the rare disease space.
In this role, the right individual will be responsible for, but not limited to the following:
- Providing strategic global regulatory guidance to cross-functional project teams responsible for product development.
- Defining and implementing regulatory strategies; works with cross-functional project teams to execute the agreed-upon strategies;
- Supporting departmental activities with regards to clinical trial conduct and regulatory submissions.
- Experience with designing and executing creative development strategies for NCE and biologics development programs.
- Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
- Comprehensive Understanding of FDA regulations and ICH guidances, as well as comprehensive experience in the drug development process.
- Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document format.
- Experience with international clinical trials and regulatory documentation.
- Expertise in translating regulatory requirements into practical, workable plans.
- Experience in preparation of critical submission documentation, and communications with FDA and other regulatory agencies.
Job requirements
Educational Requirements
- Ph.D. or Pharm. D. or equivalent experience in a scientific discipline or equivalent.
- Bachelors or Master’s Degree will be considered with relevant experience in Regulatory Affairs. Regulatory Affairs Certification is favorable.
- Minimum of 15 - 20years of regulatory experience respectively within the pharmaceutical or biotechnology (preferred) industry.
