Manufacturing/ Distribution company in Pinellas Park is searching for a Paralegal to join their team. This person must have a certification by an institution approved by the American Bar Association, experience in FDA regulation(experience in the drug/pharmaceutical industry would be best). If you are looking to bring your skills to a well known company and are eager to grown, contact me now!
- Work with Management and outside counsel to ensure company-wide compliance with current and future FDA requirements.
- Create and manage file database for all aspects of FDA product filing from establishing predicate products to final
approval of all Substantial Equivalence applications.
- Keep FDA filings organized by establishing, organizing and maintaining a filing system; monitoring calendars; meeting
deadlines and managing the communication in receiving and responding to letters issued by the FDA.
- Work with US Management, legal counsel and outside counsel to coordinate the legal review of current and
future contracts to fulfill local and global business needs.
- Obtains, identifies and shares information relating to legal needs / challenges, including but not limited to
appropriate laws, judicial decisions, and legal articles.
- Work with stakeholders, and when required external counsel, to manage Appointed Merchant Agreement
and Licensing agreements
- FDA regulations
- Legal Assistance
- Microsoft Office Suite
- Organizational Skills
- SQL database
- Years of experience: 3 years
- Experience level:Experienced
Working hours: 8 AM - 5 PM
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.