Post Name: Analyst

Department: Regulatory affairs

Grade: B

Reporting To: SM

Location: Granules – Gagillapur Plant –Hyderabad

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, Heath 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 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 document 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 promoting the values of creativity, integrity, excellence, perseverance, flexibility and respect.

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.

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