Regulatory Affairs Specialist

14 hours ago


Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000
Regulatory Affairs Specialist

An experienced professional with advanced knowledge and skills in managing complex regulatory projects, writing technical documents, and establishing relationships with clients.

Key Responsibilities:
  • Lead regulatory teams on complex projects, including technical writing and project management.
  • Write regulatory and technical documents with minimal review by senior staff.
  • Establish relationships with clients, presenting lessons learned and resolving issues.
  • Provide guidance to junior colleagues, including feedback on document quality and assisting in their training and development.
  • Presentation of regulatory deliverables to clients at bid defense meetings.
  • Development of new regulatory standard operating procedures and proposal of revisions or acting as a reviewer.
Requirements:
  • Bachelor's Degree in Life Sciences or related field (or Master's Degree).
  • At least 8 years of relevant experience.
  • Good understanding of Research and Development process, Chemistry, Manufacturing, Controls, Preclinical and Clinical laws and related guidelines.
  • Specific regulatory or technical expertise.
  • Knowledge of managing regulatory projects, project deliverables, and time-bound manner.


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