We are looking for an RA Manager, to work with the EU and US regulatory agencies, who is a team player and has good project management skills. This person should be collaborative, independent, and capable of prioritizing and working effectively in a fast-paced team environment.
This person will be responsible for, but not limited to protocol amendments, informational amendments, CMC and sections of initial IND filings, monitoring and maintenance of regulatory files throughout the product life cycle. In preparation of these filings, he/she will be responsible for interacting with internal teams to include Manufacturing, Clinical Developments, Clinical Operations, Quality Control, and Quality Assurance staff.
- Ensure compliance to applicable regulatory and quality policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.
- Work with cross-functional team to provide guidance and expertise for product development.
- Aanalyses, evaluation, preparation, and submission of documentation for the regulatory submissions in compliance with regulatory agency specifications.
- Reviews protocols and reports to support regulatory submissions.
- Assists with the preparation of departmental standard operating procedures (SOPs).
- Compile and maintain regulatory documentation databases or systems.
- Ensuring accuracy and completeness of clinical trial serious adverse event (SAE) reports received by vendor/vendor oversight; compilation of data for aggregate reports and signal detection; and compliance to regulatory reporting safety obligations.
- Support all Company initiatives as identified by management
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned
- At least MSc degree in related sciences
- Minimum 5 years of regulatory experience working with EMA or FDA, including preparation and handling of submissions
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Strong verbal and written communications
- Strong organizational and follow-up skills, as well as attention to detail.
- Experience with CMC and analytical work- advantage