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Job Details

Senior Regulatory Specialist

Company: RBW Consulting
Location: Cranbury, NJ
Reference: RAA-SRS-CNJ
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Senior Regulatory Specialist

Cranbury, New Jersey

Responsibilities:

  • Critically review source documents for ANDA/IND/NDA submissions. Provide input into content and format of the source documents to ensure compliance with current submission requirements
  • Obtain non-clinical and clinical research and associated documents required for the submission and ensure their compliance and adequacy
  • Author and review regulatory submission documents for original applications of ANDA/IND/NDA and their subsequent amendments or supplements
  • Ensure completeness of the assigned submission. Strive to have high quality submissions in terms of accurate content, in-depth and balanced presentation of the whole project
  • Work with technical departments to answer inquires or resolve deficiencies raised by the regulators. Follow-up as necessary to ensure the applications are approvable
  • Coordinate with other departments or companies to achieve regulatory project goals, either pre-approval, launch support or post-approval activities
  • Understand law, regulations and guidelines for compliance requirements. Pay attention to new regulations and advice relevant department for appropriate actions
  • Other assignments by the managements

Qualifications:

  • Bachelor Degree in Chemistry, Chemical Engineering, Pharmaceutical or related field with 1-8 years experience in pharmaceutical industry
  • Hands-on experience in R&D, Quality control or commercial manufacturing is highly desirable. Technical understanding in analytical, formulation or manufacturing process development is strongly preferred
  • Knowledge and experience of pharmaceutical regulations are preferred
  • Good writing and communication skills are required

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Senior Regulatory Specialist

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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