Senior Regulatory Affairs Services Manager

Senior Regulatory Affairs Services Manager

Synteract

Home-based, Poland

Position Overview

The Regulatory Affairs Services Senior Manager is responsible for either Regulatory Strategy, all aspects of publishing and submission of clinical and regulatory documents or a combination of both. You'll serve as the primary regulatory contact for clients with responsibility for managing regulatory timelines and resources to achieve client deliverables on time and within budget. You'll represent Regulatory Affairs Services on project teams both internally and externally providing strategic input; works closely with senior regulatory staff to plan, prioritize and coordinate regulatory document preparation and submission based on applicable global regulations. Working closely with regulatory affairs senior management, assumes a leadership role in the research, development, vendor management and implementation of electronic regulatory submissions capability for client documents and applications. Additionally, You'll identify the need for Regulatory Affairs standard operating procedures (SOPs), guidelines and work instructions, assists with their preparation and with staff training.

Specific tasks would include

  • Serves as the primary contact for regulatory clients.
  • Drives opportunities for regulatory and clinical strategic consulting activities.
  • Provides strategic regulatory input to clients and other departments and management (proposal development and project execution oversight in the field of regulatory consulting).
  • Represents the department at bid defense meetings.
  • Represents Regulatory Affairs on internal and external project teams.
  • Manages the established timelines to achieve client deliverables on time and within budget.
  • Anticipates areas with the potential to jeopardize regulatory timelines, identifies solutions and discusses these with clients.
  • Contributes to the writing and editing of regulatory and technical documents as appropriate.
  • Contributes to the review, implementation, and maintenance of the submission process and provides suggestions for ongoing process improvement.
  • Assists with regulatory intelligence by monitoring the global regulatory environment and providing regulatory summaries and dissemination of critical materials.
  • Helps prepare for, and participates in, client and regulatory authority audits and inspections.
  • Works to build contacts within the regulatory community.
  • Collaborates with other departments on new initiatives and process improvements, as requested.
  • Provides operational and technical guidance and direction to colleagues.
  • Supports projects as needed.

Qualifications

  • Bachelor's degree in business, life sciences or related field of study and 8+ years Regulatory Affairs experience in the pharmaceutical industry/Clinical Research Organization, or equivalent combination of studies and relevant work experience inclusive of substantial experience in researching, reviewing, and processing regulated documents and the demonstrated ability to provide guidance and direction to others effectively.
  • Experience with current CTD/eCTD regulations and requirements in accordance with NDA/MAA and FDA/global specifications are an asset.
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Publishing experience required for publishing role including:
    • FDA submissions.
    • Health Canada submissions.
    • EMA and European Member States submissions.
    • Clinical study report compilation.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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