Quality Assurance

3 days ago

Ankleshwar, India Zentiva Group, a.s. Full time

Assistant Manager - Regulatory Affairs

You will have the opportunity to:

- Ensure compliance with regulatory requirements and support successful registration and approval of manufactured products
- Preparation of high quality documents for Drug Product and Drug Substance as part of Product Life cycle management, New MAA, Response to HA Queries
- Management of Regulatory changes - Change Initiation, evaluation and GxP compliance
- To evaluate impact of CMC changes on registration file and to prepare and manage technical packages for different types of variations as per European variation guideline.
- To work in collaboration with Global Regulatory affairs, Global Quality, Zentiva Affiliates, Site Strategy, Supply Chain, EXIM, Production operations, Quality Assurance, Quality Control and site services to ensure timely implementation of Regulatory actions associated with Industrial projects and business priorities
- Review of GxP documents, Artworks & Labelling against registered Product Dossiers to ensure regulatory compliance
- Preparation of CMC Dossiers / Administrative documents / Response to Health Authorities viz. Module 1, Module 2 - Quality Overall Summary & Module 3 etc for products which are manufactured at Ankleshwar site and registered worldwide
- Liaising and negotiating with regulatory authorities
- Knowledge management, impart Training to Zentiva associates on Regulatory Requirements and cGMP topics.
- Other responsibilities as assigned

You will love this role/ team because:

- Excellent working environment and a passionate team of professionals;
- Continuous Learning & Development opportunities

You will strive in this role if you have:

- M. Pharm / B. Pharm with 5 to 8 years’ of experience in Pharmaceutical Industry
- Knowledge of Chemistry, Manufacturing and Controls (CMC) & Quality Management System for Pharmaceutical Formulations, Active Pharmaceutical Ingredients, D&C Act, EUDRALEX - EU Legislation, GMP requirements
- Good written and verbal communication skills, analytical skills so as to collaborate independently with Global RA / liaison with Drug Regulatory Authorities
- Motivation to travel for HA Interactions
- Ability to learn / quick adaptability / analytical /organized / communicative
- To follow requirements of solid line manager and job description.
- To follow tasks and timelines, set for particular activities and projects.
- To work independently, to be proactive

To learn more about our D&I commitment,

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