7 Module 3 Jobs

Primary Responsibilities: Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval. Responsible for writing CMC modules 2 & 3. Exposure to EU & CIS region in Regulatory filings Manage and coordinate product life cycle management. Ensure regulatory compliance with local regulatory requirements. Foster and maintain professional relationships with the health authorities. Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary. Maintain regulatory work processes and tracking tools that improve per...

Greetings of the day ! Our reputed MNC Client is hiring for: Designation: Regulatory Affairs- EU Market- Pre & Post Approval Location: Hyderabad Shift: General Work Mode: WFO (5 days working) Interview Mode: F2F interview NOTE: Looking for candidates from Generic Pharma and not from API as this is for formulation Role & responsibilities: 1. Component with EU-Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module 2. Well versed with EU- Regulatory guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH & EMEA guidelines) 3. Clear Knowledge of basic aspect...

Position: RAD-US Market, (CMC, M3) Qualification: M. Pharmacy (Pharmaceutics, Regulatory Affairs) Experience: 6-11 yrs Job Location: Hyderabad Job Type: Permanent Responsibilities: Hands on experience with RA-US market ; responsible for Approved and Tentative Approved ANDAs /NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports** /Updates etc.,) Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, an...

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinat...

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinat...

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regul...

Role & responsibilities Demonstrated experience in authoring and review of Module 3 CMC sections for post-approval CMC variations, renewals, annual reports, legal entity name change variations and other lifecycle maintenance activities, according to current government regulations and guidelines Strong experience in assessing the change control issued by quality or regulatory department. Assess the regulatory impact of the change and develop submission strategy. Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative...