Regulatory Affairs Specialist

1 week ago


Anand, Gujarat, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

**Job Opportunity**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team.

  • This role will be responsible for ensuring compliance with international guidelines and country-specific requirements.

**Key Responsibilities:**

  • Screen and analyze documents received for product registration requests.
  • Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Manage legalization or apostillation of registration documents.

**Required Skills and Qualifications:**

  • Strong knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.

**Additional Requirements:**

  • Graduate/Postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.

The ideal candidate will possess strong organizational and analytical skills, proficiency in MS Office, and excellent written and verbal communication skills.

**Benefits:**

  • Opportunity to work on high-profile projects
  • Chance to develop expertise in regulatory affairs


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