Regulatory Affairs Officer

3 days ago

Ahmedabad, India Jay Maharaj Job Placement Full time

Keep in touch with international legislation, guidelines and customer practices - Keep up to the date with a company’s product range - Ensure that a company’s products comply with the current regulations. - The Regulatory Affairs professional’s job is to keep track of the ever - changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development which colleagues are generating. - Formulate regulatory strategy for all appropriate regulatory submissions for domestic, international and/or contract projects. - Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization. - Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents. - Monitor the progress of all registration submission. against submission of DMF’s and other documents. - Respond to queries as they arise, and ensure that registration/ approval are granted without delay. - Impart training to R&D, Pilot plant, ADL and RA. Team members on current regulatory requirements. - Advising their companies on the regulatory aspects and climate that would affect proposed activities. I.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance. - Manage review audit reports and compliance, regulatory and customer inspections. - Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labeling or in advertising. - Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and effectiveness of the product. **Salary**: From ₹70,000.00 per month **Benefits**: - Cell phone reimbursement Ability to commute/relocate: - Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required) **Experience**: - total work: 6 years (preferred) **Speak with the employer** +91-XXXXXXXXXX

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