REGULATORY EXECUTIVE @ SANGHARSH
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.
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.