RA Manager

Posted 09 December 2022
Job type Permanent
Contact NameDavid Skinner

Job description

BioTalent are partnered with an exciting company to assist their search for a newly created Regulatory Affairs Manager on a permanent basis as part of their ongoing growth plans.



Key Responsibilities:


  • Maintain the approved dossiers of the lifecycle of the products
  • Ensure that Regulatory procedures and records with respect to CMC / Quality are in compliance with applicable regulations and standards
  • Prepare administrative documentation on time and Module 1 documentation for regulatory submissions / variations as well as provides support to CMC writing for initial MA submission in various regions.
  • Ensure that regulatory variations are accurate and verifiable against source documents to confirm compliance and traceability
  • Prepare submissions for new markets
  • Participate in expert discussions with different stakeholders’ prior approval and support by answering questions during the approval process
  • Maintain the Quality System for Regulatory Activities
  • Collaborate closely with external service providers (e.g. publisher or CMC writing) on Regulatory Affairs aspects
  • Support Senior Management and Line Manager in all Regulatory Affairs aspects
  • Collaborate with Regulatory Affairs functions within and outside of the company
  • Interact with Health Authorities on Regulatory Affairs aspects of the company
  • Manage Change control system and coordinate information to all relevant stakeholders on time
  • Assure post marketing surveillance regarding pharmaceutical legislation and guidance in Switzerland


Qualifications and skills:


  • You have a cooperative, self-motivated and pro-active mindset.
  • You combine excellent planning and execution skills with the ability to work effectively in international matrix organisations.
  • University degree / state examination in pharmacy or other natural sciences
  • Proven track record of 4+ years in the pharmaceutical industry in Life Cycle Management internationally with at least 3 years of GMP/GDP experience in a regulatory function, preferably as Regulatory Affairs Project Manager
  • Experience of working in different regulatory regions
  • Sound knowledge of EU, US and CH GMP/GDP regulations, in quality system requirements, as well as from biopharmaceuticals
  • Good knowledge of eCTD structure and its compilation
  • Ideally you have already submitted new applications and maintained dossiers over their lifecycle
  • Fluent in English