Regulatory Operations Specialist
ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:
- Prepare and manage regulatory submissions (e.g., supplements, amendments, correspondence to EMEA, FDA, etc.) as well as support key stakeholders in the preparation, and QC for investigational and/or marketed drug products.
- Develop relationships with key stake holders (e.g., Regulatory Operations) to establish and maintain submission planners and associated timelines and facilitates tactical submission team meetings.
- Provide support to Regulatory REMS as assigned (e.g., research regulations, guidance, submission support, etc.).
- Coordinate and support the team in planning and preparation for EMEA/FDA meetings and/or teleconferences.
- Maintain and update internal records in appropriate document management systems.
- Work with internal teams to establish appropriate procedures for submission(s) per SOPs.
- Assist with drafting cover letters, FDA forms and response documents as necessary.
- Create regulatory objectives in the appropriate document management system.
- Maintain a submission calendar and work closely with internal teams to schedule, upload appropriate documents and route documents for review and approval to meet submission deadlines.
- Lifecycle submissions, upload health authority correspondences and keep the regulatory system up to date with all submission activity.
QUALIFICATIONS:
- Bachelor’s degree in science related field, business, healthcare or other related discipline
- 1-3 years of pharmaceutical experience preferably in a regulatory environment
- Some knowledge of the regulations and processes that govern content, maintenance, and submission of controlled documents required by regulatory authorities.
- Excellent communication skills, both verbal and written.