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Job Details

Manager Regulatory Affairs

Company: CROMSOURCE
Location: United States
Reference: HQ00001207
Closing Date: 21 Mar 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Manager Regulatory AffairsLocation: Home-based, USAFull-time Permanent The Regulatory Affairs Manager is responsible for developing regulatory strategies, managing regulatory submissions, and communication with health authorities. Interactions are with US and other international regulatory authorities. He/she has a solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions including INDs, international clinical trial applications and...

Requirements:

Manager Regulatory Affairs
Location: Home-based, USA
Full-time Permanent

The Regulatory Affairs Manager is responsible for developing regulatory strategies, managing regulatory submissions, and communication with health authorities. Interactions are with US and other international regulatory authorities. He/she has a solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions including INDs, international clinical trial applications and marketing applications.

Responsibilities and Duties

  • Actively contributes to the development and implementation of regulatory strategy for assigned projects to maximize the likelihood of regulatory success and to mitigate risk
  • Provides scientific, technical and consultancy services to clients regarding regional and/or global regulatory development, approval and commercialization of medicinal products and devices
  • Prepares, coordinates, manages the regulatory submissions to the Regulatory Authorities in accordance with applicable regulations and guidance
  • Monitors and reviews the technical and commercial progress of regulatory projects
  • Interfaces with external regulatory groups (e.g. CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions
  • Acts as liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross-functional team meetings
  • Reviews and communicates current and emerging regulatory requirements (e.g. US and international regulations and guidelines)
  • Leads all communications between regulatory agencies and Sponsors acting as US Agent in accordance with 21 CFR 312.23(a)(1)(ix); 316.22; and 803.58
  • Identifies and executes plans to successfully develop regulatory personnel. Guides, mentors and motivates inexperienced regulatory affairs staff
  • Maintains regulatory research databases on relevant fields
  • Writes and reviews all internal SOPs related to regulatory affairs to ensure compliance with current laws and regulation

Qualifications and Skills

  • University Degree in scientific, medical or paramedical disciplines
  • Seven years (at least) of RA experience
  • Excellent knowledge of FDA, EMA, ICH-GCP, MDD, AIMDD, ISO EN 14155, other relevant international regulations
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel
Regulatory & Scientific Affairs Manager, Regulatory Affairs Associate, Regulatory Affairs Executive, Regulatory Affairs Manager, Senior Regulatory Affairs Executive

Apply for this job: Manager Regulatory Affairs

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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