Regulatory Affairs Specialist

11 hours ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title:

Regulatory Affairs Specialist - CMC


Job Description:

This position involves supporting submissions to regulatory authorities and managing the lifecycle of products. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.

Key Responsibilities:
  • Prepare, review, and compile high-quality regulatory submissions in electronic format, including responses to queries from regulatory authorities.
  • Maintain compliance with regulatory requirements, including post-submission regulatory filing deadlines.
  • Author and review documentation related to chemistry, manufacturing, and controls (CMC), ensuring it meets regulatory standards.
  • Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
  • Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
  • Support the development of regulatory strategies by identifying critical issues and responding to queries from regulatory authorities.
  • Review and approve change controls from global partners to assess regulatory impact.
Requirements:
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
  • At least 3 to 7 years of experience in Regulatory Affairs, preferably with experience in submissions to regulatory authorities.
  • Strong knowledge of regulatory requirements, particularly those related to CMC.
  • Excellent oral and written communication skills.
  • Ability to work independently and in a team environment.
  • Proficiency in Microsoft Office Suite, with strong skills in Word and Excel.
  • Detail-oriented, with excellent communication and collaboration skills.

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