Regulatory Affairs Specialist
4 weeks ago
Our client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Regulatory Affairs Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference
Type of Role: 1.5 year contract
Schedule: M-F 8a-5p
Pay: $35/hr
Regulatory Affairs Specialist Key Responsibilities:
- Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems.
- Assist with preparing high quality US regulatory submissions required by local and federal agencies for company products.
- Ensure that all submissions are prepared per established requirements and submitted within established timelines. Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies.
- Contribute to the development and implementation of applicable work processes and instructions.
- Maintain advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas.
- Understand and monitor regulatory trends; understand and implement regulations and guidance.
- Interfaces with relevant stakeholder groups as needed to ensure compliance.
- Provide training for team members in assigned areas of responsibility.
- Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of company products and processes.
Regulatory Affairs Specialist Education/Experience:
- Associate’s degree and 5 years of relevant experience OR Bachelor’s degree and 3 years of relevant experience
- Regulatory Affairs experience required
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