Assistant Manager – CMC Regulatory
The Assistant Manager – CMC (Chemistry, Manufacturing, and Controls) Regulatory will be responsible for the preparation and management of regulatory filings, including ANDA (Abbreviated New Drug Application) submissions for the US and other global markets. This role requires a detailed understanding of regulatory guidelines, timelines, and a proactive approach to ensuring compliance with all relevant regulations. The position is based in Goa and is crucial for maintaining the regulatory compliance of pharmaceutical products.
Key Responsibilities
- ANDA Regulatory Filing: Prepare and submit ANDA filings for the US and other markets in accordance with regulatory guidelines and timelines.
- Review and Filing: Ensure the timely review and submission of annual reports, supplements, variations, and RFI (Request for Information) responses for all approved products in the US market.
- Document Review: Review essential documents such as Product Development Reports, Master Batch Manufacturing and Packing Records, process validation protocols and reports, hold time study protocols and reports, stability protocols, product quality review reports, and Comparative Dissolution Study Protocols and Reports to meet regulatory requirements.
- Change Control and Deviations: Assess change controls and deviations according to US market requirements, including new ANDA, SUPAC (Scale-Up and Post-Approval Changes), and other post-approval guidelines.
- Information Management: Gather, manage, and collate information from respective stakeholders to support regulatory submissions and compliance activities.
- Regulatory Updates: Stay updated with changes in regulatory legislation and guidelines, particularly those affecting the US market.
Executive – Drug Labeling
- Labeling Preparation: Prepare Drug Facts (DF) labeling in compliance with 21 CFR 201 labeling requirements.
- Master Label Copy (MLC): Develop and maintain Master Label Copy (MLC) for approved Over-the-Counter (OTC) products.
- OTC Templates: Review and maintain OTC labeling templates to ensure accuracy and compliance.
- Draft Labeling: Assist in the development of draft labeling for proposed and existing drug products, ensuring alignment with National Brand and Reference Listed Drug (RLD) standards.
- Artwork Review: Review artwork for accuracy and compliance with labeling requirements, including the review of Key Line Dimension (KLD) and die lines.
- Regulatory Compliance: Monitor global regulatory and labeling requirements to ensure compliance with internal and external standards.
Interested candidates can apply by sending their resume to info@adaptisls.com
