Granules Hiring Analyst – Chemistry & Pharma Candidates Apply
Job Opportunity with Granules who is Translating Science & Technology into High-Quality Pharmaceutical Products for over 3 decades. Chemistry job opening, Pharmacy job vacancy 2021, Interested and eligible candidates may check out all the details on the same below:
Department Regulatory affairs
Job Title Analyst
Grade B
Reporting To SM
Location Granules – Gagillapur Plant –Hyderabad
Qualifications and Experience
Master’s degree or equivalent in Pharmaceutical or Chemistry or Pharmacy or Life Sciences
3-8 years experience in Regulatory affairs – API DMF filings.
Knowledge and Skills
- Candidates must have experience of working in a generic pharmaceutical company.
Demonstrated interpersonal skills. - Knowledge and application of ICH Guidelines, DMF, EDMF / GMPs, GLPs, and GCPs principles
Purpose
Provide support as a team member of Regulatory affairs in supporting various works on DMF filings and Queries handling.
Responsibilities
- Provide support for Compilation of dossiers (Drug master files) and submitting to various regulatory agencies.
- Preparation of dossiers as per USFDA, EDQM, ASMFs, Health Canada, WHO, and other regulatory agencies dossier requirements.
- Preparation of responses to queries received from customers and regulatory agencies.
- Experience in change controls evaluation.
- Preparation of DMF Amendments/CEP revisions/Other DMF updates to support life cycle management of the product.
- Hands-on exposure in pharma-ready eCTD software handling for US, Europe, and Canada markets requirements.
- Ensuring the PDF properties of Dossiers for uploading into pharma-ready eCTD software based on regulatory market requirements for converting PDF documents in to XML backbone. Further, the complete dossier is zip filed and submitted in to ESG gateway of USFDA and CESP portal of EU agencies.
- Liaising with internal customers and stakeholders to ensure coordination of all projects.
Provide support for continuous improvement in existing procedures/practices/compliance of department. - Provide support in the overall management of the Regulatory Affairs department and create a healthy environment of teamwork and empowerment, and promote the values of creativity, integrity, excellence, perseverance, flexibility, and respect.
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