Senior Regulatory Affairs Associate job in San Clemente
Vacancy has expired
San Clemente CorTech LLC
| Job Ref: | 354530 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 54.22/Per Hour |
| Remote: | No |
Location |
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| City: | San Clemente |
| Post Code: | 92673 |
| Map: |
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Description |
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JobsRUs.com. is seeking to hire a Senior Regulatory Affairs Associate for our client in San Clemente, CA! Benefits Available! Weekly Pay! 54.22 per Hour Shift 1st Shift 8 to 5 Position Summary Provides regulatory support and expertise associated with drug product registrations for I.V. Solutions portfolio, including in-depth analysis of the requirements and tracking of deliverables. Executes submission strategies to maintain drug product registrations in line with regulatory requirements and guidelines. Assures full regulatory compliance of all documentation for submissions. Essential Duties and Responsibilities Provides regulatory support for maintenance of commercial drug products with minimal oversight. Independently prepares drug product submissions in alignment with regulatory strategy. Assesses scientific data provided for submission purposes to ensure it meets regulatory requirements. Identifies gaps in drug product submission and executes plans to mitigate risks with management oversight. Responsible for tracking and completion of assigned drug product registration activities and commitments. Accountable for accuracy of work and meeting deadlines. Makes independent judgments and decisions based on regulations and professional experience, with management oversight as appropriate. Supports special projects and process improvement initiatives as assigned. Knowledge and Skills Strong project management skills and ability to manage multiple drug product submissions simultaneously. Sound knowledge of applicable portions of agency regulations and guidance documents. Able to follow scientific arguments. Excellent oral and written communication skills. Excellent interpersonal skills. Minimum Qualifications, Education and Experience A degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related field that will assist with technical writing and in problem solving technical issues as they relate to global drug product registrations. Minimum of seven years of pharmaceutical industry experience with a minimum of five years in Regulatory Affairs with direct experience authoring drug product submissions. Experience successfully preparing drug product application supplements and obtaining associated approvals. Experience successfully preparing Annual Reports and PADERs. Experience successfully preparing and maintaining Type III Drug Master Files for container closure systems. Advanced experience with authoring global drug product registrations. | |
ref: (354530)
661 days ago
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