Regulatory Affairs Specialist

2 weeks ago


Mumbai, Maharashtra, India Piramal Group Full time

**Job Overview:**

We are seeking an experienced Regulatory Affairs Specialist to manage regulatory filings for the Europe market with minimal supervision. As a key member of our team, you will be responsible for submitting product registration dossiers to targeted countries in Europe as per eCTD requirements.

Responsibilities:

  • Submit product registration dossiers to targeted countries in Europe as per eCTD requirements.
  • File all required variations and renewals of assigned products in line with guidelines and checklists as per the plan.
  • Respond to queries received from regulatory agencies, business units, or other stakeholders by ensuring complete and accurate information is provided within predefined timelines.
  • Review product labeling updates in EU.
  • Maintain various databases in a timely manner.
  • Update yourself with relevant current EMEA, National, and ICH guidance's and requirements.
  • Provide required support to Pharmacovigilance teams as and when required.
  • Ensure support in execution of any projects assigned as per business needs.

About Us:

Piramal Group is a global pharmaceutical company committed to delivering high-quality healthcare solutions. We offer a dynamic and challenging work environment that fosters growth and development. Our employees enjoy a competitive salary package, including a base salary of ₹600,000, plus benefits such as medical insurance, retirement plans, and paid time off.

Requirements:

  • Minimum 5 years of experience in handling Europe market.
  • Strong communication skills both spoken and written English.
  • Ability to multitask and handle multiple projects simultaneously.
  • Good technical knowledge and ability to review documents.

Location:

This role is based in Kurla, Mumbai, India. Travel is expected to be low.



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