Planet Pharma
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Regulatory Affairs Specialist III
role at
Planet Pharma
Location: Irvine, CA
Salary: $45,000 - $55,000
Role
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.
Requirements
Must have experience with WindChill.
Pay $45,000-55,000 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.
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Regulatory Affairs Specialist III
role at
Planet Pharma
Location: Irvine, CA
Salary: $45,000 - $55,000
Role
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.
Requirements
Must have experience with WindChill.
Pay $45,000-55,000 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.
#J-18808-Ljbffr