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Senior Regulatory Affairs Project Director Job
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| Employer Name: |
SpiderID: 2328031 |
| Location: Silver Spring, Maryland |
Date Posted: 7/1/2008 |
| Wage: $130,000.00 |
Category: Biotech |
| Job Code: 1512 |
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| Number Of Openings: 1 |
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Job Description:
(multi-year regulatory affairs project)
The individual will be responsible for managing a team of regulatory affairs professionals and activities that include the preparation and/or technical and administrative review of investigational drug/biologics regulatory documents (INDs and CTAs), devices (IDEs and 510(k)), and combination products.
The individual will be responsible for (1) developing and implementing project management systems (2) ensuring the best use of resources for the efficient operation of the project; and (3) that the regulatory team meets required schedules.
In addition, the individual will be responsible for the following: (1) ensuring that the regulatory team resolves issues in dealing with regulatory authorities (FDA, Health Canada, European Union regulatory authorities); (2) providing regulatory compliance in support of new or modified pharmaceutical products and/or combinations products; (3) ensuring that QA systems are in place for the administrative and technical review of, and actions on regulatory related materials; (4) providing cGCP and GXP training to government staff, investigators, and clinical site staff; (5) overseeing the management of specialized expertise support services; (6) and ensuring that required QA, GXP audits are accomplished.
Minimum requirements include a PhD or equivalent in biomedical or life sciences; strong leadership skills and the ability to establish sound working relationships with staff and the client; supervisory management experience; strong knowledge and direct experience in FDA submission and approval processes; a minimum 10 years of "hands on experience" related pharmaceutical experience and regulatory drug/biologics and device development experience; experience and knowledge of current FDA, Health Canada, and European Union regulatory authorities’ requirements and industry standards; and excellent verbal and written communication skills
SSS offers an excellent compensation and benefits package, including 4 weeks of paid leave, health benefits, 401K, and ten paid holidays a year. SSS is an employee-owned company. EOE M/F/D/V
Job Requirements:
I would prefer someone from the commercial pharmaceutical side, but someone with managerial experience in the FDA might be okay. Salary DOE.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 10 or more
Education Required: Doctoral
Overnight Travel:
Vacation Time:
Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave
Contact Information:
| Contact Name: Recruiter |
Company Type: |
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| City: Taylor |
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| State: Michigan |
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| Zip: |
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