Regulatory Affairs, Specialist III

Join to apply for the Regulatory Affairs Specialist III role at Planet Pharma

Location:

Irvine, CA

Salary: $45,000 - $55,000

• Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
• Demonstrates working knowledge of healthcare-related regulations.
• Demonstrates in-depth knowledge of preparing a submission.
• Demonstrates in-depth knowledge of industry and competitive products.
• Applies relevant regulations and statutes to further product submissions of basic to medium complexity.
• Contributes to the strategic direction of regulatory pathway development.
• Refines and conforms the preliminary data used in the submission process.
• Translates technical data and descriptions into reviewer-friendly content.
• Helps to ensure that the appropriate regulatory requirements for the submission are met.
• Interacts with regulatory body to help further product approvals or clearance.
• Has in-depth experience, knowledge and skills in own job family.
• Applies knowledge and skills to a wide range of standard and non-standard situations.
• Works independently with minimal guidance.
• Usually determines own work priorities.
• Acts as a resource for colleagues with less experience.

• Must have experience with Wind Chill.
• Pay $45, based on experience level.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.