Assistant Manager RA

Roles and Responsibilities

• Manage ANDA dossiers, CTD submissions, and regulatory documentation for solid oral products.
  
• Oversee product registration processes from dossier preparation to marketing approval.
  
• Ensure compliance with regulatory requirements for injectable products.
  
• Maintain accurate records of all regulatory activities and updates.
  
• Coordinate with cross-functional teams for timely submission of applications and reports.
  

Desired Candidate Profile

• 8-13 years of experience in Regulatory Affairs (RA) or related field.
  
• Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma).
  
• Strong understanding of pharmaceutical regulations, including FDA guidelines and ICH standards.
  
• Proficiency in creating high-quality regulatory documents such as CTAs, CTDs, eCTDs, Module 2.5 & 2.7.
  
• Interested candidates can share their profile on pratik.joshi@acmegenerics.in (9909998982)