Ayala Pharmaceuticals is currently looking for an RA Associate, to work with the EU and US regulatory agencies, who is a tram 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, safety reports, 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 Development, 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.
- Analyses, 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.
- 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 either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions- advantage