Associate Director, Regulatory Affairs - Device job Princeton New Jersey
Associate Director, Regulatory Affairs - Device job Princeton New Jersey
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Associate Director, Regulatory Affairs - Device Job

Employer Name: SpiderID: 7699841
Location: Princeton, New Jersey Date Posted: 6/29/2018
Wage: Negotiable Category: Medical/Health
Job Code: 240445BR

Job Description:
The Associate Director, Regulatory Affairs will be responsible for PDMA compliance and regulatory approval of all digital therapeutic product line marketing and professional material, selling documents and promotional materials through PRC. Must have working knowledge of Device regulations [510(k), IDE and PMA]. The incumbent will also be responsible for interpreting pre-clinical/clinical trials, data collection, pharmacology, toxicology, drug metabolism, and clinical research in support of 505(b)(2) applications. Facilitate and support the due diligence and co-development of compounds through the various stages of clinical research; collaborate with all disciplines within the Company. Help prepare quality documents for submission to regulatory agencies to permit the legal distribution of pharmaceuticals for clinical or commercial purposes.

BA/BS/MS/Ph.D. in Biological or Pharm Science. Required BA/BS, Preferred MS/PhD.  Fluent in English required 7-10 years regulatory or related experience in the pharmaceutical industry. Excellent written and verbal communication skills. Knowledge of regulatory requirements, guidance's and regulations (US) within the pharmaceutical industry, specific to the areas of clinical research, product development and labeling.

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: Sandoz Company Type:
Company: Sandoz

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