Executive ra jobs in India

We are looking for a Regulatory Affairs Executive with hands-on experience in DMF preparation dossier compilation and regulatory query handling. · Prepare dummy Drug Master Files including both Open Part Applicant's Part and Closed Part Restricted Part. · ,Collect review required ...

We have an opening for RA Executive - Dossier Compilation. · ...

· Job Description: · Position: RA Executive (Khopoli) · Location: Khopoli - Raigarh · Experience: Years · Industries:      Pharma  · Responsibilities: · Dossier Preparation & Submission · Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global ...

Prepare dossier for Europe, Australia, Canada and New Zealand region. · Drafting response to agency query · Review propose changes received from cross function group and identified variation requirements · ...

Finished Product: - Approved COA, electronic data review checklist, raw data, worksheet, working standards/reference standards details, instruments calibration status, acceptance criteria as per specification and MOA verify and update observations. · In-process samples: - Approve ...

This role involves preparing and issuing regulatory documents, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements. · ...

Preparation of the Dossiers for New/RenewalVariations/Query response/Tender for Europe, UK,  US, Canada and Australia Market · ...

The job requires a person to review and verify quality control data, instruments calibration status, and acceptance criteria as per specification and MOA. They must also evaluate out-of-specification (OOS), out-of-trend (OOT), lab deviation, and lab incident investigation reports ...

· Job Description: · Position: Executive - QA/RA · Location: Dabhel - Daman · Experience: Year · Industries:      Pharma  · Responsibilities: · Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities · Coordinate with various ...

Strong knowledge of QA/RA standards EU & US pharmacopoeia Experience in audits certifications and dossier preparation Proficiency in MS Word Excel Outlook Certification in Quality Management ASQ CQM etc preferred · ...

As Regulatory Affairs Executive at Sun Pharma you will be responsible for regulatory submission of new products, renewals and variations for MENA markets. · Prepare CMC dossiers for fresh submissions and review documents before initiation of Exhibit batches. · Review and prepare ...

Job Title · Executive – Regulatory Affairs · Business Unit · R&D1 Regulatory Affairs · Job Grade · G12A · Location · Baroda · At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey ...

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As an Executive – Regulatory Affairs at Sun Pharma in Baroda you will help create your own sunshine by fostering an environment where you grow at every step take charge of your journey and thrive in a supportive community. · ...

Regulatory submission of new products, renewals, variations, response to queries and Life cycle management for MENA markets through preparation of quality dossiers enabling timely approvals. · ...

This role involves regulatory submission of new products and renewal for MENA markets through preparation of quality dossiers to enable timely approvals. · ...

Review and finalize CMC documents for regulatory submissions. · Draft, compile and review eCTD sections ensuring compliance with current regulatory standards. · Collaborate effectively with cross-functional teams to gather required information. ...

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We believe that when diverse skills and perspectives unite under a shared purpose and value system, · we can achieve remarkable outcomes, · driving innovation and excellence across the pharmaceutical landscape. · ...

Lead regulatory submissions for Oral Solid Dosage (OSD) for the US market. · Ensure timely and compliant responses to product deficiencies raised by US regulatory authorities, including the USFDA. · ...