Regulatory Affairs - CMC - ClinicalPosted: November 5, 2009
Jobs Clinical New Jersey Regulatory Affairs - CMC Regulatory Affairs - CMC Company: Aerotek Scientific Location: Roseland, New Jersey Category: Clinical Jobs Rate: Based on experience. Job Type: Contract Posting ID: 1995207 Posting Date: 11/2/2009 Allegis Group Family of Hiring Companies Apply Online for this Job Today Already a Member? If youre currently a thingamajob.com member? Please apply here. Apply with Your Account Not a Member? Were hiring. Create an account and you can apply for some of the most desirable Clinicaljob opportunities in the country. Apply with a New Account Regulatory Affairs - CMC Job Description: Responsibilities: - The primary purpose of this position is to manage post approval CMC activities for US and International Pharmaceutical products. - Review CMC post approval changes and provide regulatory assessments for US and International Pharmaceutical products. - Develop regulatory strategy for efficient approvals. - Prepare CMC submissions for US and International Health. - Respond to questions from the Health Authorities related to CMC submissions. - Provide regulatory support to technical groups, manufacturing sites, research, quality, and marketing as needed. Experience: - Minimum 5 years pharmaceutical experience. - Strong knowledge of pharmaceutical processes. - Experience preparing CMC submissions US/EU/International CMC experience is desirable. - Experience assessing post-approval CMC changes. Education: - Bachelor of Science degree (minimum). Required Skills for Regulatory Affairs - CMC Job: * CMC SUBMISSIONS * CMC POST APPROVAL CHANGES * BIO/PHARMACEUTICAL About Aerotek Scientific: Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, were constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know its more than just your day-to-day responsibilities that can make or break a job. Its the support you get. Thats the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Dont put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers. Contact Information Alicia Miller Apply Now! Begin by filling out the "Apply Online for this Job" section at the top of the page Need Directions? Get office driving directions with Google Maps almiller@aerotek.com Aerotek Scientific - Parsippany, NJ 600 Parsippany Road Suite 101B Parsippany, NJ 07054 TEL: (973) 560-5025 FAX: (973) 560-5090 Please refer to job code 1995207 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
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> Regulatory Affairs
| | Location: | Roseland, NJ | | County: | Essex County | | ZIP Code: | 07068 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | Aerotek | | Phone: | email only please | | Fax: | email only please |
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