Regulatory Officer

Natural Remedies

0 - 2 years

2 - 4 Lacs

bengaluru

Posted:11 hours ago| Platform:

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Skills Required

regulatory affairs ctd submission regulatory ectd pharmaceutical sales

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & Responsibilities:

Ensure compliance with applicable laws, regulations, and guidelines related to the company's products or services.
Regulatory Submissions: Prepare, review, and submit regulatory documents to relevant authorities, such as product registrations, notifications.
Documentation Management: Maintain accurate and up-to-date regulatory documentation, including product technical files, labeling, and manufacturing records. Collaborate with cross-functional teams to provide regulatory guidance and support during product development stages. Review product specifications and documentation to ensure compliance.
Regulatory Liaison: Communicate and interact with regulatory authorities or third-party consultants to address inquiries, resolve issues, or obtain necessary approvals.
Regulatory Audits: Assist in preparing for and participating in regulatory audits or inspections. Address any findings or observations and implement corrective actions.
Quality Assurance: Participate in quality assurance activities, including conducting internal audits, implementing corrective and preventive actions, and ensuring compliance with quality standards.
Risk Management: Assess and mitigate regulatory risks associated with product compliance, labeling, advertising, or post-market surveillance.
Cross-functional Collaboration: Collaborate with various departments, such as QA,QC R&D, and marketing, to ensure alignment with regulatory requirements.
Regulatory Reporting: Prepare periodic reports on regulatory activities, metrics, or performance indicators for management or regulatory authorities.

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