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Director, Regulatory Affairs Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2373731 |
| Location: Meriden, Connecticut |
Date Posted: 7/16/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6513313 |
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Job Description:
This position will be the primary point of contact with licensing/development partners for regulatory strategic matters. The incumbent will be responsible for the growth and adaptation of the Regulatory Affairs department to meet the needs of the company. Will represent the company as needed for regulatory affairs matters. Main responsibilities include: lead the Regulatory Affairs Department in the required regulatory related strategy for all research & development candidates and approved products, including line extensions, participates in the development project teams to create and communicate regulatory strategy, and for strategic planning and submission of documentation to regulatory agencies as appropriate, such that development timelines and compliance with regulations can be maintained. Will be responsible for ensuring that the company is in compliance with regulatory requirements for all ongoing projects; assures that the documentation being provided to regulatory authorities meets standards for completeness and compliance with regulations and company best practices; ensures that communications with other groups (Q A , QC, Manufacturing, Process Development, clinical, research, etc) to write and generate such documentation occurs and when necessary take the lead in generation / authoring of documents, acts as the liaison for information requests to and from Regulatory agencies, and is responsible for tracking their progress.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: PharmaceuticalCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.pharmaceuticalcrossing.com
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