Regulatory Affairs Executive

We are seeking a passionate and experienced Regulatory Affairs Executive to join our dynamic team at CONNOTE HEALTHCARE PVT LTD. This full-time, mid-level position based in Ahmedabad requires a candidate with a strong understanding of regulatory standards and processes. The successful candidate will play a crucial role in managing the company's regulatory submissions, ensuring compliance, and facilitating product registrations to support our expansion into new markets.

Qualifications and Skills

• Expertise in ROW Market, understanding nuances in regulatory demands across regions (Mandatory skill)
• In-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions (Mandatory skill)
• Proficiency in handling technical documents to facilitate accurate and timely submissions (Mandatory skill)
• Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance
• Strong analytical skills to assess regulatory data and provide critical insights for decision-making
• Experience in dossier preparation, organizing comprehensive documents for regulatory authorities
• Attention to detail to meticulously handle documentation and regulatory records
• Excellent communication skills to liaise with regulatory agencies and internal departments
  
  
  

Job Location

Ahmedabad

Roles And Responsibilities

Review of Dossiers and Queries.

• Maintain the status of respective countries.
• Review of Guidelines for First-time dossier preparation for any new country.
• Renewal Application
• Ensuring planning and proper organization of regulatory activities and resources within the team.
• Independent interaction with the plant team for technical documents.

Desired Skills and Experience

ROW Market, FDA Guidelines, technical documents, Review skills, Analytic Skills, Dossier Preparation