Regulatory Affairs US Market Ahmedabad: Lead US Submissions at Cadila Pharmaceuticals

Are you a seasoned regulatory affairs professional with expertise in the US market? Cadila Pharmaceuticals Ltd. is seeking a skilled Regulatory Affairs US Market Ahmedabad professional to join their team in Dholka, Ahmedabad. This is a pivotal role for individuals with a minimum of 6 years of experience, focused on managing US regulatory submissions.

 you will be responsible for the compilation, review, and submission of registration dossiers for the US market, handling regulatory queries, and managing post-approval activities. This role offers a unique opportunity to contribute to the success of a leading pharmaceutical company.

Why Join Cadila Pharmaceuticals?

• Established Leader: Be part of a reputable and growing pharmaceutical company.
• Significant Impact: Play a key role in bringing pharmaceutical products to the US market.
• Professional Growth: Enhance your expertise in US regulatory affairs.
• Collaborative Environment: Work with a team of experienced professionals.

Key Responsibilities of the Regulatory Affairs Professional:

• Compilation, review, and submission of registration dossiers for the US market.
• Handling regulatory queries and deficiencies.
• Managing post-approval activities (Annual Reports, CBE-0, CBE-30, PAS submissions).
• Utilizing eCTD software for ANDA/IND submissions, query responses, and post-approval submissions.
• Reviewing and approving functional documents (Specifications, Test Procedures, Validation Protocols, etc.).
• Reviewing Analytical method validation/verification/transfer reports.
• Reviewing DMF and its notifications.
• Reviewing and approving Change Controls and Deviations.
• Creating and maintaining a regulatory database for all submissions.
• Tracking regulatory guidance documents.
• Imparting training on new guidance documents.

Essential Skills and Qualifications

To excel in the role of Regulatory Affairs US, candidates should possess:

• Minimum 6 years of experience in regulatory affairs, specifically for the US market.
• Strong understanding of US FDA regulations and guidelines.
• Proficiency in eCTD software and ANDA/IND submissions.
• Experience in handling regulatory queries and post-approval activities.
• Excellent documentation and communication skills.
• Ability to review and approve technical documents.
• Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.

Detailed Responsibilities

• US Regulatory Submissions:
  • Prepare and submit high-quality ANDA/IND dossiers.
  • Ensure compliance with FDA guidelines and regulations.
  • Manage timelines and deliverables for submissions.
• Post-Approval Activities:
  • Prepare and submit post-approval supplements (CBE-0, CBE-30, PAS).
  • Review and submit annual reports.
  • Manage change controls and deviations.
• Documentation and Compliance:
  • Maintain accurate and up-to-date regulatory documentation.
  • Ensure compliance with all regulatory requirements.
  • Review and approve documents related to manufacturing, testing, and validations.

Regulatory Database and Training

• Create and maintain a comprehensive regulatory database.
• Track and disseminate information on new regulatory guidance documents.
• Provide training to team members on regulatory updates.

Location and Application Process

• Location: Dholka, Ahmedabad, Gujarat
• To apply, please send your CV to [email protected].

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