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Job Details

Associate Director, Regulatory Affairs – Labelling

Company: RBW Consulting
Location: Basking Ridge, New Jersey
Reference: RAA-ADRAL-BRNJ
Closing Date: 12 Oct 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:

Associate Director, Regulatory Affairs – Labelling

Basking Ridge, New Jersey

Responsibilities

  • Prepare regulatory documents (Drug Launch Labelling, US Prescribing Information, Annotated Labelling, Patient Insert, Medication Guide, Prescriber Brochure, Proprietary Name Requests, NDA Annual Report and Core Data Sheets) in paper and electronic format. Liaise and negotiate NDA labelling with FDA; strategize and plan for FDA meetings
  • Participate in global product team meetings (development and marketed products); provide regulatory support (IND/NDA, TPP process, INN Preparation, Drug Product Recalls) and guidance and manage day-to-day regulatory activities
  • Collaborate with all disciplines within the organization to obtain and/or provide information/data for regulatory filings.
  • Review and interpret regulatory guidelines.
  • Review RA and related documents for approval

Qualifications

  • BS degree in chemistry, biology or other related scientific discipline required. Masters or PhD preferred or equivalent experience
  • 7+ years in the pharmaceutical industry. 3+ years in global regulatory affairs.
  • Knowledge and support of Drug Product Labelling, Patient Inserts, medication Guides, Prescriber Brochures, Proprietary Name Requests, Core Data Sheets, Labelling Manuscripts, electronic submissions, and global document management.
  • Ability to manage and coordinate several global projects simultaneously. Ability to provide regulatory guidance.
  • Ability to build team relationships and interface in a global team environment at all levels of management.
  • Good organizational, planning and multi-tasking abilities; good oral and written communication skills.
  • An ability and understanding of where to seek regulatory information.

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: Associate Director, Regulatory Affairs – Labelling

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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