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REGULATORY EXECUTIVE @ SANGHARSH

0 Negotiable or Not Mentioned India, Ahmedabad 23 days ago sangharsh.biz 1239 Views

Sangharsh is seeking a dedicated and experienced Regulatory Executive to join our expanding pharmaceutical team in Ahmedabad. This role is pivotal for an individual with a minimum of 5 years of experience in Regulatory Affairs, specifically within the pharmaceutical sector. The successful candidate will be responsible for the preparation, compilation, and submission of CTD and ACTD dossiers, ensuring that all documentation meets the rigorous standards required for international markets. You will also manage the lifecycle of products across various global markets, including ROW regions like Nigeria, Myanmar, Kenya, Uganda, Tanzania, Ethiopia, Cambodia, Sudan, and regions across CIS and LATAM. Coordination closely with cross-functional teams is essential to ensure all regulatory submissions are made on time.

Beyond dossier preparation, the Regulatory Executive will handle and respond to regulatory queries and deficiencies, maintaining high standards of documentation and communication throughout the process. We are looking for candidates with a strong understanding of regulatory guidelines for international markets and hands-on experience with Microsoft Office, Adobe PDF tools, and modern AI tools for documentation and task management. If you are an M.Pharm graduate ready to take on a challenging and rewarding role in a fast-growing pharmaceutical organization, we encourage you to apply. Candidates who are immediate joiners and can start within one month are highly preferred for this position.

Key Requirements

Minimum 5 Years of experience in Regulatory Affairs within the Pharmaceutical industry. Educational qualification of Master of Pharmacy (M.Pharm) is required. Strong expertise in the preparation, compilation, and submission of CTD/ACTD dossiers. Proven experience in lifecycle management of products across multiple global markets. Ability to handle and respond effectively to regulatory queries and deficiencies. Excellent coordination skills with cross-functional teams to ensure timely submissions. Comprehensive understanding of regulatory guidelines for ROW (Rest of World) markets. Hands-on experience with Microsoft Office tools for professional documentation. Proficiency in using Adobe PDF tools for dossier compilation and editing. Familiarity with AI tools for documentation and modern task management platforms.
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REGULATORY EXECUTIVE @ SANGHARSH

0 Negotiable or Not Mentioned India, Ahmedabad 24 days ago sangharsh.biz 1321 Views

Sangharsh is looking for a highly skilled and experienced Regulatory Executive to join our expanding pharmaceutical team in Ahmedabad. The successful candidate will be responsible for managing regulatory affairs across various international ROW markets, including Nigeria, Myanmar, Kenya, Uganda, Tanzania, Ethiopia, Cambodia, Sudan, and regions such as CIS and LATAM. This role requires a professional capable of operating in a fast-paced environment, ensuring all products comply with international regulatory standards and guidelines.

The primary responsibilities include the preparation, compilation, and submission of CTD and ACTD dossiers, along with managing the lifecycle of products across global markets. You will be expected to coordinate with cross-functional teams to ensure timely submissions and handle responses to regulatory queries or deficiencies effectively. Candidates with an M.Pharm degree and at least 5 years of experience in Regulatory Affairs within the pharmaceutical sector are encouraged to apply. Immediate joiners who can start within one month are highly preferred for this position.

Key Requirements

Minimum 5 years of experience in Regulatory Affairs within the Pharmaceutical industry. Master of Pharmacy (M.Pharm) degree from a recognized institution. Proven expertise in the preparation, compilation, and submission of CTD and ACTD dossiers. Extensive knowledge of regulatory guidelines for ROW markets including Nigeria, Kenya, and Tanzania. Experience in managing the lifecycle of pharmaceutical products across multiple global territories. Ability to handle and respond to complex regulatory queries and deficiencies from health authorities. Strong proficiency in Microsoft Office suite for reporting and documentation. Advanced hands-on experience with Adobe PDF tools for dossier preparation. Familiarity with using AI tools to enhance documentation and regulatory processes. Excellent coordination, communication, and task management skills.
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