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Job Details

Manager, US Regulatory Affairs - Global Development Projects (GDP)

Company: RBW Consulting
Location: Florham Park, New Jersey
Reference: RA-RAMUSA-FPNJ
Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Benefits Package

Job Summary:

Our client is a leading pharmaceutical company. They are in a unique position of having the financial backing and the research capabilities of a well-established leading pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.

Requirements:

Manager, US Regulatory Affairs

Florham Park, NJ

Our client is a leading pharmaceutical company. They are in a unique position of having the financial backing and the research capabilities of a well-established leading pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.

The client develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain, women’s health and anti-infectives.

They are seeking dynamic, focused and creative individuals to join their growing team. They are currently expanding our workforce in their New Jersey headquarters location and looking for experienced pharmaceutical professionals to help them build for the future.

The Manager, US Regulatory Affairs - Global Development Projects (GDP) will assist the department with: completing regulatory correspondence and submissions; assembling IND and NDA submissions; performing Quality Control reviews of regulatory submissions

Key  Responsibilities

  • Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed
  • Support larger submissions, such as INDs and NDAs, including organizing the submission review process, preparing sections, reviewing for completeness, accuracy, and appropriateness, and formatting for submission
  • Interpret and advise regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance
  • Offer leadership on project teams with regard to regulatory issues
  • Establish contact with the FDA as required to support developmental programs
  • Support and assist with the development of regulatory strategy for US approvals of drugs
  • Ensure necessary clinical trial information is posted on clinicaltrials.gov, and that all listings are updated appropriately

Job Requirements

  • Bachelor’s degree in Science (e.g. Chemistry, Pharmacy, Biochemistry)
  • Minimum of 5 years of Pharmaceutical industry experience with at least 3 of those years in Clinical Development Operations or a Regulatory position
  • Working knowledge and experience in regulatory submissions and product life cycle management
  • Knowledge of drug regulations and guidances with ability to apply to complex regulatory issues and requirements
  • Ability to simultaneously plan, coordinate and lead activities on multiple projects
  • Ability to self-direct workload, including reprioritizing and delivery under tight timelines
  • Excellent written and oral communication skills
  • Detail-oriented team player capable of multitasking and prioritizing
  • Adaptable to changing priorities
  • Proficient in the use of common Microsoft software programs
  • Experience interacting with Health Authorities
  • Experience developing eCTD-compliant documents
  • Ability to analyze and communicate scientific information from a broad range of disciplines
  • Excellent writing, editing, verbal, and interpersonal communication skills, and strong attention to detail
  • Familiarity with CTD, ICH, GCP, and other standards

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 (646) 586 9087 today!

Apply for this job: Manager, US Regulatory Affairs - Global Development Projects (GDP)

Contact Information:

Address:  US Team
Origin Two 106 High Street, Crawley
RH10 1BF
England
Tel:  (646) 586 9087
Website:  Visit Our Web Site

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