||Responsible for the regulatory operations for project development activities and assistance of project management for global clinical studies.
|Essential Duties and
(Include but not limited to
Other duties may be assigned)
- Plan, implement, manage and report regulatory activities and submission timelines for global clinical studies.
- Manage review, formatting and ensure regulatory documents to be submission ready to FDA (and HC).
- Manage archive of IND (and CTA) publication and regulatory documents submitted to FDA (and HC).
- Provide regulatory guidance to ensure IND, NDA and any application related communications with FDA (and HC).
- Assist Program Manager of a development project to plan, implement, manage and report project management activities for global clinical studies.
- Manage project development timeline and cost, and help to ensure that project activities are delivered on time and on budget.
- Organize and facilitate meetings internally and with outside parties.
- Research on regulatory and competitive information, including FDA guideline and announcements, press releases and scientificconferences and publications, etc.
- Perform other task and function as required or needed.
- Full functional knowledge of US regulatory requirements pertaining to the development and registration of biological or oligonucleotide-based products
- Experience with IND and NDA filings is required
- Working and/or in-depth knowledge of clinical and CMC aspects of regulatory affairs
- Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma,Nippon Shinyaku (HQ, Japan), external partners and vendors.
- Strong computer skills, and proficient inMS applications (Word, Excel, PowerPoint)
- Ability to handle multiple tasks and prioritize
- Strong organizational, communication and presentation skills
- Team player, flexible, ability to adapt to change
- Bachelor's degree is required with a Master's degree or higher (PhD, PharmD) preferred plus appropriate level of pharmaceutical industry and regulatory affairs experience.
- Minimum of 5 years of regulatory experience in the biotech/pharmaceutical industry; experience in the hematological malignancies, neuromuscular or orphan diseases is a plus. Practical experience with biologics and small molecules, as well as experience dealing with multiple aspects of regulatory affairs (CMC, clinical, nonclinical) is strongly preferred.