Regulatory Affairs Manager - Pharmaceuticals
Location :
Philadelphia PA US 19103
Job Type :
Direct
Reference Code :
18671-AB1
Compensation : 100000.00 - 120000.00 USD/YEAR
Start Date :
03/11/2020
Hours :
Full Time
Required Years of Experience :
5
Required Education :
BS Chemistry
Travel :
No
Relocation :
No
Job Industry :
Pharmaceutical
Job Description :
- Permanent position for a Regulatory Affairs Manager to complete regulatory correspondence, review and assemble IND and NDA submissions, and develop regulatory strategy.
- Develop regulatory strategy for US drug approvals. Establish contact with the FDA.
- Complete FDA submission documentation with cover letters.
- Ensure clinical trial information postings are complete and up to date.
- Provide support to senior regulatory personnel for IND and NDA submissions by preparing, formatting, and reviewing sections.
- Serve as point of contact on topics of regulations, key issues, risks and other critical topics to maintain regulatory compliance.
- Provide leadership to regulatory project teams.
Required Qualifications :
- BS Chemistry, Pharmacy, Biochemistry, Biology or other science degree
- Minimum 5 years regulatory experience in a pharmaceutical company.
- Experience in regulatory submissions, knowledge of drug regulations, and the ability to apply to complex regulatory requirements.
- Experience interacting with FDA and other Health Authorities.
- Experience providing regulatory submissions in Electronic Common Technical Documents (eCTD).
- Familiarity with national and international standards including CTD, ICH, and GCP.
- Detail-oriented with good organizational skills to plan, coordinate and lead activities on multiple projects.
- Excellent interpersonal skills to scientific information. Excellent written and verbal communication skills.
Contact: Allan Berman
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Please send all inquiries to allan.berman@terkotech.com
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