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Sun Pharma- Walk-in Interview For Regulatory Affairs On 3rd December 2023

Australia, New South Wales, Central Coast
Last update 2024-04-18
Expires 2024-04-17
ID #2101203670
Free
Sun Pharma- Walk-in Interview For Regulatory Affairs On 3rd December 2023
Australia, New South Wales, Central Coast,
Modified April 4, 2024

Description

Sun Pharma- Walk-In Interview For Regulatory Affairs on 3rd December 2023, Job Location: R&D Baroda Date: Sunday, 3rd December 2023, Time: 9.30 am -1.00 pm Venue of Interview : Sun Pharmaceutical Industries Ltd – Sun Pharma Road, Tandalja – Baroda - 390016 Department: Regulatory Affairs API Grade: Executive Experience:2 - 4 years Brief Job Description: Minimum 2yrs of experience in regulatory affairs/quality assurance of API Plant or corporate.

Good understanding of basic DMF compilation and lifecycle management requirement.

Good understanding of Change control and related submission requirement 2) Department: Regulatory Affairs Formulation - US Qualification: M.

Pharm Grade: Executive / Sr.

Executive Experience:3 - 6 years Brief Job Description: 1) Review all data and documents related to product registrations for various health authorities.

2) Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/ New Zealand, Japan and Israel.

3) Prepare responses to deficiency letters received from various agencies 4)) Maintain life-cycle / post approval changes for drug product registration dossiers.

5) Provide regulatory support to cross functional departments.

6) e CTD compilation, verification and submission through electronic gateway 3) Department: Regulatory Affairs Formulation - US (Labeling) B.

Pharm/ M. Pharm Grade: Sr Officer / Executive Experience:1-6 years Brief Job Description: 1.

Original Application submission : Labeling development for original applications (NDA/ ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve-outs based on patents and exclusivity claims 2.

Labeling Query responses and Patent Amendments : Thorough review/ interpretation of FDA comments.

Review of revised labeling and response.

Tracking/ Review for Completeness/ Timely Submission.

Review of patent amendment 3) Life Cycle Management : Track RLD labeling changes.

Initiate labeling revision activity as per RLD label revision/ safety labeling change ?SLC? notification from FDA 4) Department: Regulatory Affairs Formulation - US (e CTD) B.

Pharm Grade:1-6 years Experience: Sr Officer / Executive Brief Job Description: 1) Regulatory submission/publishing activities for e CTD global submission dossiers according to Agency and ICH Guidance requirements.

(US and other advanced markets).

2) Electronic Document Publishing (i.e.

PDF file preparation as per e CTD requirement, bookmarking/ linking, compilation/ publishing in software.

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Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Sun pharma- walk-in interview for regulatory affairs on 3rd december 2023

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