Regulatory Affairs Officer

6 days ago

Vadodara, India Asoj Soft Caps Full time

Responsibilities

As a regulatory affairs officer:

  • ensure that a company's products comply with the regulations of the regions where they want to distribute them
  • keep up to date with national and international legislation, guidelines and customer practices
  • respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.
  • collect, collate and evaluate scientific data from a range of sources
  • develop and write clear arguments and explanations for new product licences and licence renewals
  • prepare submissions of licence variations and renewals to strict deadlines
  • monitor and set timelines for licence variations and renewal approvals
  • work with specialist computer software and resources
  • write clear, accessible product labels and patient information leaflets
  • plan and develop product trials and interpret trial data
  • advise scientists and manufacturers on regulatory requirements
  • provide strategic advice to senior management throughout the development of a new product
  • project manage teams of colleagues involved with the development of new products
  • oversee product trials and interpret trail data
  • undertake and manage regulatory inspections
  • review company practices and provide advice on changes to systems
  • liaise with, and make presentations to, regulatory authorities
  • negotiate with regulatory authorities for marketing authorisation
  • take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities

Preferred candidate profile

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