126 days ago on altran.ch

Regulatory Affairs (RA) Consultant f/m

Altran AG

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Regulatory Affairs (RA) Consultant f/m

  • Job Title
    Regulatory Affairs (RA) Consultant f/m
  • Vacancy Reference Number
  • Work Site
    Switzerland / | CHE - All Regions / Zürich
  • Contract Type
    Permanent [Full-Time]

Your role

  • Coordination and preparation for new submissions, regular updates, variations, renewals: Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions
  • Collaboration and communication with customers to develop and align regulatory filing strategies (renewal, transfer, withdrawals) and implementation plans
  • Coordination and preparation of responses to deficiency letters, authority requests, customer requests
  • Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.)
  • Regulatory assessments of Change Requests, major Non Conformances and development of regulatory implementation plan
  • Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
  • Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
  • Regulatory support for inspections and audits
  • Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities

Your profile

  • Bachelor's degree with 6+ years of Regulatory Affair experience in pharmaceutical industry or a MSc. /PhD. with 4+ years of experience.
  • Strong Regulatory Affair experience
  • Good knowledge of global HA laws, regulations, and guidance is required
  • CMC experience is preferred
  • Experience developing regulatory strategies and an understanding of drug product development is preferred.
  • Solid understanding of chemistry relevant is preferred.
  • Excellent interpersonal, teamwork and verbal/written communication skills.
  • Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously
  • Communicates cross-functionally and cross-company as well and presents and defends regulatory strategy and opinion to project teams.
  • Good knowledge of English.