Regulatory Operations consultant (part time)

  • Thoothukudi
  • Rk Cmc Consulting Corp

Company Description Spark CMC Consulting Corp provides Regulatory CMC authoring and strategy support to the pharmaceutical industry for pre- and post-approval submission activities. The company is dedicated to ensuring regulatory compliance and success for pharmaceutical companies.

Role Description This is a part-time remote role for a Regulatory Operations consultant at Spark CMC Consulting Corp. The consultant will be responsible for providing support in regulatory CMC authoring and strategy for submission activities. Day-to-day tasks include dossier pre-publishing and publishing activities. Experience with systems such as Veeva Vault, eCTD Builder, eCTD Manager, Global Submission platforms is helpful. Will be working directly with the clients, managing operations, and ensuring high-quality customer service.

Qualifications Regulatory Operations / Submissions experience Analytical and Consulting skills Excellent Communication and Customer Service skills Ability to work independently and remotely Experience in regulatory operations or pharmaceutical industry is a plus Bachelor's degree in a related field