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Trainee Officer Regulatory Affairs

1 month ago

Ahmedabad, India Biotech Healthcare Full time

Role Objective:The Trainee Officer – Regulatory Affairs will be responsible for assisting in the preparation, compilation, and review of regulatory documents to ensure compliance with country-specific guidelines. This role provides an opportunity to develop expertise in regulatory requirements, documentation processes, and dossier submissions, contributing to the organization's regulatory strategy.Desired Candidate Profile:Education: M.Pharm in Regulatory Affairs.Experience: Fresher (0-1 year of experience in regulatory affairs or a related field is preferred).Skills: Basic understanding of regulatory requirements, strong analytical abilities, attention to detail, and effective communication skills.Attributes: Ability to learn quickly, work in a team environment, and handle multiple tasks efficiently.Role & Responsibilities:Document screening and analysis:Assist in screening regulatory documents as per registration requirements.Verify document requirements against country-specific guidelines.Communicate document needs to relevant teams.Dossier preparation and submission:Support in preparing, compiling, and reviewing product dossiers.Ensure timely submission of dossiers as per project timelines.Coordinate with teams for dossier submissions in different markets.Document Legalization and Coordination:Assist in the legalization and apostillation of regulatory documents.Coordinate with agencies to obtain attested documents.Training and Awareness:Participate in training sessions on regulatory processes and compliance requirements.Gain knowledge of country-specific regulatory guidelines.Regulatory Query Management:Support in reviewing and responding to regulatory queries.Assist in preparing compliance-related documentation.Supportive Document Arrangement:Help in arranging batch-related documents such as DOCs and COAs for registration samples.Document Management:Maintain updated records of product technical files.Ensure consistency of technical content across product categories.Technical Document Support:Assist in updating technical documents such as Clinical Evaluation Reports, Risk Management Reports, and General Safety and Performance Requirements (GSPRs).Post Market Surveillance (PMS):Support the periodic update of PMS reports for all products.Functional Skills Required:Basic knowledge of regulatory guidelines and requirements.Understanding of document preparation and submission processes.Analytical skills for document screening and requirement analysis.Behavioral Skills Required:Strong communication and interpersonal skills.High attention to detail and organizational abilities.Ability to work independently and collaboratively.Capability to manage multiple tasks and meet deadlines.Problem-solving mindset and adaptability to regulatory changes.This role offers a structured learning opportunity for fresh graduates to build a career in regulatory affairs, ensuring compliance and contributing to the regulatory success of the organization.Important Links:Website:LinkedIn:Instagram:Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.