199 days ago on altran.ch

Regulatory Affairs (RA) Consultant

Altran AG

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 Please refer to JobSuchmaschine in your application

Regulatory Affairs (RA) Consultant

  • Job Title
    Regulatory Affairs (RA) Consultant
  • Vacancy Reference Number
    02313
  • Work Site
    Switzerland / | CHE - All Regions / All Regions
  • Contract Type
    Permanent [Full-Time]


Our offer

  • You will join the Global leader in Engineering and R&D Services (ER&D), offers its clients a new way to innovate by developing the products and services of tomorrow.
  • You will be working alongside its clients on every link in the value chain of their project, from conception to industrialization.
  • Become part of the Group, which has provided its expertise for over 30 years to key players in the Aerospace, Automotive, Defense, Energy, Finance, Life Sciences, Railway, and Telecoms sectors, among others.
  • In 2016, the Altran group generated revenues of €2bn, including headcount of more than 28,000 employees and presence in more than 2x countries worldwide, in Switzerland with a strong presence in Zurich, Basel, Lausanne and Geneva.
  • More info on the Group Vision IGNITION 2020:  http://ignition.altran.com/en/altran2020-ignition

Your role

  • Coordinate and prepare new submissions, regular updates, variations, and renewals: Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions
  • Collaborate and communicate with customers to develop and align regulatory filing strategies (renewal, transfer, withdrawals) and implementation plans
  • Coordinate and prepare responses to deficiency letters, authority requests, customer requests
  • Prepare and submit Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamine free Statement, Latex free Statement, etc.)
  • Do Regulatory assessments of Change Requests, major NonConformances, and develop a regulatory implementation plan
  • Develop a Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
  • Prepare FDA-GDUFA (Generic Drug User Fee Amendments) applications
  • Establish Regulatory support for inspections and audits
  • Partner with Global Regulatory groups to coordinate and ensure submission of filings for the 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 an MSc. /Ph.D. 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 in the development of regulatory strategies and an understanding of drug product development is preferred
  • Solid understanding of chemistry relevant is preferred
  • Interpersonal, teamwork and verbal/written communication skills (cross-functional and cross-company communication)
  • Good organizational skills, multitask and handle projects, priorities and complex systems simultaneously
  • Good knowledge of English is mandatory, German is a plus