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Regulatory Affairs Manager Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2359064 |
| Location: San Antonio, Texas |
Date Posted: 7/10/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6305902 |
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Job Description:
Customer Service and logistics functions to ensure distribution is controlled so that only appropriately cleared or approved products are sold; supports new product development teams by assessing regulatory requirements; collaborates with the Medical Department in establishing clinical study priorities that support product approvals; assures the company\'s compliance with regulations and promotes a strong working relationship with agencies and organizations that governs the Company\'s product; ensures that advertising and promotional activities are compliant with appropriate regulations and guidance. To meet these requirements, the successful candidate will be a strong team player who participates directly in building a high performance team. Job Responsibilities This position includes the following essential roles and responsibilities. Other duties may be assigned consistent with current and emerging business priorities Assists in establishing regulatory strategies leading to new product submissions in support of corporate goals and objectives Manages, motivates, mentors, coaches and develops Regulatory Staff Manages preparation of documentation for submissions for new product or new intended uses for existing products Establishes regulatory strategies to obtain the appropriate regulatory clearances/approvals for existing products in terms of modifications to intended use, design, labeling, materials, manufacturing location, product brand name, corporate name, country of origin, and manufacturing processes Maintains an electronic database of US and Canadian clearances, approvals and licenses ages projects by establishing project timelines to ensure effective resource management and to facilitate project review. Participates in product development teams Reviews and approves labeling content, product and process changes, and product documentation as it pertains to regulatory filings and clinical trials Reviews advertising and promotional materials to ensure conformance with regulatory approvals Assists with the coordination of activities across departmental lines and between contractors or consultants to prepare product submissions and updates for regulatory agencies Writes, revises and reviews revisions of Regulatory Affairs policies and procedures.
For more information, please click here to visit us at PharmaceuticalCrossing
For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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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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