Ambix Healthcare Hiring For Regulatory Affairs
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| Ambix Healthcare Hiring For Regulatory Affairs |
Hiring for a Regulatory officer based at Ahmedabad - for Ahmedabad location near science city
Job Requirements:-
Assist in the preparation, compilation, and submission of regulatory documents, including but not limited to drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies.
Maintain and update regulatory documentation and databases, ensuring accuracy, completeness, and compliance with regulatory requirements and internal standards.
Coordinate regulatory activities with internal stakeholders, including R&D manufacturing, quality assurance, and marketing teams, to ensure alignment with regulatory requirements and project timelines.
Review and assess manufacturing and quality control documentation, including batch records, specifications, and validation reports, to ensure compliance with regulatory standards and guidelines.
Support regulatory assessments and audits by internal and external parties, including regulatory agencies and customers, by providing documentation and information as requested.
Monitor changes in regulatory requirements and guidelines applicable to finished pharmaceutical manufacturing, and communicate updates to relevant stakeholders to ensure ongoing compliance.
Assist in the preparation of responses to regulatory inquiries, deficiency letters, and requests for additional information from regulatory agencies, ensuring timely and accurate responses.
Participate in regulatory training and education programs for employees to enhance awareness and understanding of regulatory requirements and best practices.
Contribute to continuous improvement initiatives within the Regulatory Affairs department, including process optimization, standardization, and implementation of best practices.
Perform other duties and responsibilities as assigned by the Regulatory Affairs Manager or other senior management personnel to support departmental objectives and organizational goals.
Additional Requirements:
Qualification : Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related field. Advanced degree (e.g., M.Pharm, MSc) preferred.
Experience : Minimum of 1-3 years of experience in regulatory affairs roles within the pharmaceutical industry, with exposure to finished pharmaceutical manufacturing processes.
Knowledge of regulatory requirements and guidelines applicable to finished pharmaceutical products, including but not limited to ICH guidelines, GMP regulations, and pharmacopoeial standards.
Familiarity with regulatory submission processes, documentation requirements, and electronic submission systems (e.g., eCTD).
Strong attention to detail and organizational skills, with the ability to manage multiple tasks and priorities effectively in a fast-paced environment.
Excellent communication and interpersonal skills, with the ability to collaborate cross-functionally and interact with internal and external stakeholders.
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint) and regulatory databases/software applications.
Proactive and self-motivated attitude, with a commitment to continuous learning and professional development in the field of regulatory affairs.
interested candidate can share their cv's at
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