Director Regulatory Affairs

Pharmaceutical Clinical Associates, LLC  - Raritan, NJ
Monday, January 18, 2010



Essential Duties and Responsibilities

1. Direct the preparation (content ) of submissions (INDs, IND amendments, CTAs, CTA amendments, BLAs and BLA supplements and periodic reports) to the Health Agencies. Responsible for coordination with Regulatory CROs for CTA activites if appropriate.
2. Responsible for direct coordination /liaison between Health Agency representatives and function groups within Company.
3. Provide guidance to multifunctional development teams concerning strategic decisions and health authority interactions.
4. Responsible for liaison activities with functional groups within Company to ensure timely and accurate reporting of information.
5. Participates in the creation, review and revision of the department policies, work instructions and standard operating procedures.

Experience and Skills:

Contact Dan Meyer at 704.399.4666 or by email dmeyer1@bellsouth.net

Additional Information:

Job Level: Management
Number of Openings: 1

Years of Experience: At least 7 Years
Level of Education: BA/BS

Salary: TBD
Starting Date : March 1, 2010

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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.



Raritan, NJ

Raritan, New Jersey



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