Senior Regulatory Associate - CTA

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. United Kingdom
London, England
Posting date: 30 Oct 2020
33886

Proclinical has partnered with a global pharmaceutical organisation in search for a Regulatory Affairs Senior Associate. The Regulatory Affairs Senior Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects.

Job Responsibilities

  • Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission)
  • Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
  • Coordinate collection of functional documents in support of regulatory applications
  • Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
  • Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
  • Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
  • As appropriate may participate in GRT to support execution of regulatory strategy
  • Respond to specific requests from and communicate relevant issues to GRT
  • Support the development and execution of GRT goals
  • Review regional component of the Global Regulatory Plan and provide input to operational deliverables
  • May support RRL in review of promotional materials for commercial activities
  • Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
  • Support process improvement initiatives, standards development, and metrics

Skills and Requirements

  • Graduate in a life science subject as a minimum, post graduate degree desirable
  • Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred
  • Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications
  • Keeps up to date with professional knowledge, expertise and best practice.
  • Excellent oral and written communication skills.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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