Regulatory Affairs Professional

2 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000
Regulatory Affairs Professional

Job Overview:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements for products, managing the submission process for regulatory approvals, and maintaining up-to-date knowledge of regulatory changes.

Main Responsibilities:
  • Compliance Management: Ensure products comply with relevant regulatory requirements, such as FDA, EMA, and local regulations.
  • Submission Preparation: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.
  • Software Proficiency: Have good knowledge about regulatory software's like eCTD Global, Educe Solution.
  • Competency: Thorough knowledge in filling DMF/Master files/Submissions to countries like Europe, UK, Australia, Brazil, GCC, Jordan, Switzerland, Ukraine, Tunisia, Singapore, Mexico.

Key Skills and Qualifications:

  • Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills are required for this role.
  • Communication and Project Management: Excellent communication and project management skills are essential for success.
  • Teamwork: Ability to work effectively in a team environment is crucial.

About this Role:

This is an exciting opportunity for a motivated individual to contribute to the success of our organization by ensuring compliance with regulatory requirements and managing the submission process for regulatory approvals.

What We Offer:

In return for your hard work and dedication, we offer a competitive compensation package that includes benefits such as professional growth opportunities and a supportive work environment.

Contact Information:

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