Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Specialist/Manager, Global Regulatory Affairs

Company: Worldwide Clinical Trials
Location:
Reference: VN 732
Closing Date: 26 Feb 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

SUMMARY: The Senior Specialist, Regulatory Affairs provides project representation and input to projects awarded to WCT for all stages of the drug development cycle.

Requirements:

Senior Specialist/Manager, Global Regulatory Affairs - US based

Company: Worldwide Clinical Trials Ltd
Location: Home/Office US based

Permanent

Job summary: Exciting opportunity within a leader global CRO which provides full drug development services to the pharmaceutical and biotechnology industries from Early Phase and Bioanalytical Sciences through Phase I , II and III trials to peri-approval studies.  The company is looking for a Senior Specialist or Manager Regulatory Affairs to join their expanding Site Activation and Regulatory Affairs group in US

Requirements:

Full-time permanent position for a Senior Specialist or Manager who will provide regulatory oversight to clinical studies awarded to Worldwide in North America region  for all stages of the drug development cycle (from phase I to IV) and will ensure the smooth running of the Regulatory Affairs activities within studies. As the role is global, after a period of training and coaching, the candidate will have the opportunity to be involved in Clinical Trial Application (CTA) submissions in regions outside North America.

KEY RESPONSIBILITIES:

  • Effectively and rapidly coordinate & manage IND  to FDAand Institutional Review Board/Independent Ethics Committees (IRB/IEC) submissions for clinical studies in US and maintain approvals in  North America region
  • Attending meetings with FDA (pre-IND, End-of-phase 2 or pre-phase 3 meetings etc.) when requested
  • Coordinate & manage submissions of initial CTA and amendments to Health Canada
  • After a period of training and coaching, the candidate will be involved in global projects with  the responsibility of managing CTA submissions to regulatory authority and ethics committees and maintain approvals in regions outside North America
  • Ensure high quality performance of deliverables are applied within the projects assigned and      promptly identify and address any risk/potential risk by implementing preventive measures
  • Provide regulatory strategic advice to internal and external customers
  • Contribute towards the preparation and/or review of technical documentation (i.e. protocol, IMPDs and IBs) when required
  • Review and, if applicable, customise all relevant documentation (i.e. labels, patient information sheets, diary cards, etc) to ensure high level of quality and compliance with ICH GCP & country specific requirements
  • Assist RA-BIDs and senior management in securing new business or repeated business by participating to BDMs, developing/ reviewing regulatory sections of proposals and regulatory costing and budgets

 

SKILLS AND EXPERIENCE:

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
  • Minimum 7 years within pharmaceutical/CRO industry, of which at least 5 years as regulatory lead in global clinical trials
  • Experience in Investigational New Drug (IND) Applications to FDA and IRB/IEC in US.
  • Experience in attending meetings with FDA such as pre-IND, End-of-phase 2 or pre-phase 3 meetings etc.
  • Previous experience in submissions of CTA to Health Canada would be desirable.
  • Proven ability to successfully manage  projects in start-up
  • Excellent organizational and management skills
  • Outstanding written and verbal communication skills and interpersonal skills
  • Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
  • Ability to exercise sound judgment and make decisions independently
  • Expert knowledge of ICH GCP and the FDA Regulation and guidelines
  • Expert knowledge of drug development

Apply for this job: Senior Specialist/Manager, Global Regulatory Affairs

Contact Information:

Address:  Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
W1T 7NS
England
Tel:  0207 121 61 61
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.