What are the responsibilities and job description for the Regulatory Affairs Associate position at ProKatchers LLC?
Job Title : Regulatory Affairs Associate II
Location : San Clemente, CA 92673
Duration : 12 Months
Shift Details : 100% On-Site
Job Description:
• Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• RAC Certification preferred
Proven strong understanding of FDA, EU and worldwide submission requirements.
• Proven strong record of preparing regulatory submissions and obtaining approvals.
• A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
• Able to assess scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload and multitask with minimal supervision.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding regulatory and business needs with ability to engage cross functional team members.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members.
Salary : $35