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Regulatory Scientist, Global Regulatory Affairs

Location: Allschwil
Sektoren Pharma & Life Sciences
Anstellungsart Temporär
Gehalt Swiss Franc70 - Swiss Franc80 per hour
Reference: BBBH141813

Regulatory Scientist, Global Regulatory Affairs

Experis IT is Europe's leading IT recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across a number of professional sectors, with IT being at the heart of our operations.

For one of our clients specialized in the pharmaceutical industry we are looking for a Regulatory Affairs Specialist with experience in Pulmonary Hypertension / Orphan Diseases.

This is a contracting position starting in October until the end of June 2022 with extension possibilities.

Responsibilities:

  • Responsible to manage own capacity and assist visibility of capacity for their work group and for RSMO.
  • Responsible for assigned projects to ensure strategic regulatory alignment across all functional areas. Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products. Provides regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate. Provides guidance and support to product development teams on regulatory issues.
  • Provide other general support on an as needed basis e.g., provide regulatory input and follow-up for inspections, audits, litigation support and products complaint.

Must Haves:

  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent
  • Experience in regulatory affairs
  • Understanding of the drug development process and regulatory submission and approval process
  • Knowledge of the regulatory environment, guidelines and practices of region
  • Required Technical Competencies & Knowledge:
  • Regulatory Affairs competencies and proficiency levels vary based on role and level and may include: Applied Technical Knowledge, Busines Acumen, Decision Making and Prioritization, External Focus, Leading and Influencing and Persuasive Communication.
  • Submissions Knowledge of regulatory requirements related to submissions and of filing registration process. Understands dossier component requirements
  • Ability to critically review and compile dossier components
  • Understands submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PSUR's, renewal applications
  • Knowledge of Microsoft programs as well as electronic management systems (e.g. ERIS, GRAIL) Regulatory Intelligence
  • Understands competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issues
  • Up-to-date knowledge of current and pending approvals in specific therapeutic areas. Knowledge of laws, guidances and requirements and their implications related to specific therapeutic areas
  • Basic medical/scientific understanding in a clinical area Regulatory Strategy
  • Provide strategic input and technical guidance on regulatory requirements to development teams
  • Understands life cycle of drug product from discovery through marketing and post-approval requirements
  • Ability to interpret and apply local regulations and guidances to the life cycle of a drug product
  • Basic medical/scientific understanding of clinical trials and drug development Health Authority Expertise
  • Knowledge of how Health Authorities operates
  • General knowledge of HA organizational structure and individual responsibilities in those structures
  • General knowledge of HA timelines for reviewing submissions
  • Organize and assist in executing HA meetings

Location: Allschwil

Start Date: 16/08/2021

End date: 30/04/2022

Workload: 100%


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