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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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