Executive/Senior Executive, Regulatory Affairs

Location: Ahmedabad/Mumbai

Job Specification:

  • Candidate must have minimum 5-6 years of work experience in the field of regulatory affairs covering markets like US, EU and other emerging markets.
  • Candidate must be a Graduate/Post Graduate in Pharmacy or Life sciences. (In exceptional cases, the candidate with equivalent pharma work experience with non-pharma academics can be considered.)
  • Candidate must have ability to determine priorities of responses when working on multiple projects.
  • Candidate must have technical expertise to de-bottleneck issues related to work management / communications; escalate major issue to the seniors for speedy resolution.
  • Excellent self-evaluation skills to identify training needs for further self - development.
  • Candidate must have flexibility to work in different time zones to meet business needs if required.
  • Must have good command over English language.

    Job Description:

  • Compile the dossier (CTD Module 1 to Module 5 or equivalent) ensuring all the relevant documents are present and complete to comply with all national requirements for submission by minimizing transcriptional errors; under guidance from seniors
  • Evaluate post approval changes for eg.: variations, site transfers, MATs, renewals, PSURs and compile suitable package in consultation team leaders.
  • Provide inputs for any ad-hoc questions/projects.
  • Understanding of Module 1 / Administrative requirements for registrations worldwide.
  • Effective coordination with seniors for project deliverables within standard timelines
  • Effective coordination with PMs for completing project deliverables within stipulated timelines.
  • Respond to comments and queries received from PMs and internal stake holders in consultation with seniors. 
  • Smooth interdepartmental partnering, collaboration, interactions and co-ordination.
  • Active involvement in regulatory intelligence through various set processes and ongoing interaction with project management teams.
  • Ensure relevant databases, project status files etc are up to date at all times for all activities by providing the needed information to the managers.
  • Attend trainings organized for team members on dossier information, dossier compilation, deficiencies, administrative requirements specific to geographies etc.
  • To understand the Pharmacovigilance requirements of key geographies like EU & US.

Application Form

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