Suffolk is Educated

Regulatory Affairs Manager

Overview

Contract Pharmacal Corp. (CPC) develops, manufactures and packages premium pharmaceuticals, over-the-counter drugs and dietary supplements. Owned and operated by the same family that founded the company in 1971, CPC today employs over 900 of the most highly skilled, experienced professionals in the industry and to date has commercialized over 4,000 products. For more company information, please visit www.cpc.com.

 

CPC is offering a professional, stable work environment with excellent opportunity for career advancement in a dynamic company, a competitive salary and a comprehensive benefits package, which includes medical, dental, life insurance, paid time-off, and 401(k) plan with matching contributions.

For immediate consideration, apply online at http://cpc.com/career_listing/regulatory-affairs-manager/

Description

Prepare, coordinate, and manage regulatory submissions of NDAs/ANDAs in accordance with applicable FDA guidelines (CBE-30, CBE-0, PAS, annual reporting)
Stay up-to-date on current GDUFA/MDUFA requirements, FDA facility registration (through Electronic Submission Gateway (ESG).
Assist with product development projects
Prepare and approve product dossiers and various regulatory documents
Support customers’ registration process
Support various departments as necessary with regulatory guidance

Qualifications

  • ◦Bachelor’s degree required, Masters preferred in regulatory affairs, legal, compliance or related
  • ◦At least 3 years of experience working in pharmaceutical Regulatory or Compliance required
  • ◦Experience in compiling documents in CTD format
  • ◦Experience in filing annual and periodic reports for NDA/ANDA submissions
  • ◦Experience with eCTD software preferred.
  • ◦Ability to read and interpret regulatory guidelines as they apply to submission documents
  • ◦Demonstrate understanding of finished product manufacturing technologies
  • ◦Proper knowledge of the industry regulations (Pharma, Legal) including 21 CFR (Code of Federal Regulation), cGMPs as related to US FDA and EU EMEA
  • ◦Analytical; ability to compile, manage and interpret data
  • ◦Clear and concise communicator; effectively present and write
  • ◦Self-starter; results oriented, driven to succeed with a sense of urgency
  • ◦Problem solver
  • ◦Team Player who has demonstrated success leading a cross-functional team

Apply Now

Job Snapshot


Type:

Full Time

Posted:

2/12/18

Company Snapshot


Company:

Contract Pharmacal Corp.

Location:

Hauppauge, NY

Industry:

Pharmaceuticals

Established:

1971

Website:

www.CPC.com