Regulatory Affairs Associate
- The Regulatory & Quality Affairs Associate ensures that the company has access to pharmaceutical and controlled substance products for our customers while protecting against fraud, deception and unsafe practices in the distribution, handling and use of these products.
- Assists in ensuring that the company is compliant with all federal and state laws on all products distributed.
- Will be responsible for communicating with both internal and external customers.
- The Associate will support the Customer Compliance team within the Regulatory Affairs & Quality Department. DUTIES AND RESPONSIBILITIES :
- Performs research on regulatory related topics appropriate to area of responsibility
- Provides recommendation and information to supervisor / manager
- Assists Customer Compliance team with their daily tasks, which include updating licensing in internal system, new customer account setup, resolving order issues, communication with state licensing boards, etc.
- Continues to learn and applies regulations as appropriate Begins to leverage experiences in conflict management
- Evaluates and resolves minor product compliance issues with internal and external customers
- Evaluates and escalates major issues to manager
- Assists and oversees the maintenance of regulatory record keeping and systems
- Organizes information and documentation / systems to ensure completeness and ease of use
- Adheres to timelines and milestones set by supervisor / manager
- Provides metric data in areas of responsibilities / task Identifies and develops Standard Operation Procedures / Working Instructions associated to area of responsibility
- Gains understanding of Federal and State regulations for DEA, FDA, EPA, OSHA, GMP
- Carries out duties in compliance with established business requirements
- Performs all other duties as required EDUCATION :
- High school diploma required.
- Preference for an Associate’s Degree and / or Bachelor’s degree in Chemistry, Biology, Health Administration, Animal Health, Business, Nursing, Pharmacy, Microbiology. WORK EXPERIENCE :
- Minimum of 2 years of work related experience with exposure to a regulatory environment. TECHNICAL SKILLS :
- Ability to follow stated processes and procedures
- Good verbal and written communication
- Attention to detail
- Capable of multi-tasking
- Ability to work in a team environment
- Ability to work under supervision
- Basic Skills in Microsoft office applications
Education : High School
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Job posted: 2021-02-03