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Senior Specialists (Gr 16)

India, Ahmedabad · Job Posted June 10, 2026
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Job Responsibility

  • With direction, develop and execute regulatory project plans
  • Identify and elevate key areas of regulatory risk
  • Maintain regulatory files in a format consistent with requirements
  • Maintain awareness of regulatory requirements
  • identify relevant requirements
  • Participate as an active team member and provide regulatory advice to project teams as required
  • Respond to questions from regulatory authorities within strict timelines
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Maintain and update existing regulatory authorizations
  • Support regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and SOP’s
  • Represent or lead Regulatory Affairs in small project teams

Requirements

  • Knowledge of regulations
  • Scientific knowledge
  • Project management skills
  • Manage multiple projects and deadlines
  • Ability to multitask and prioritize
  • Interpersonal and communication skills
  • Negotiation skills
  • Technical system skills (e.g., word processing, spreadsheets, databases, online research)
  • Ability to identify compliance risks and escalate when necessary
  • Bachelor’s degree or country equivalent in a scientific discipline
  • Minimum of 2 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization

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