Ind-Swift Hiring Drug Regulatory Affairs Executive/Officer/Sr. Officer

Ind-Swift Laboratories is seeking talented professionals to join our team as Executive/Officer/Sr. Officer in Drug Regulatory Affairs at our R&D Centre in Panchkula. This is a fantastic opportunity to contribute to developing and approving cutting-edge pharmaceutical products for global markets.

Job Details

Designation:

• Executive/Officer/Sr. Officer – Drug Regulatory Affairs

Location:

• R&D Centre, Panchkula

Qualifications:

• B.Pharm/M.Pharm

Experience:

• 3–5 years in regulatory markets, including EU, MHRA, and USFDA

Key Responsibilities

1. Preparation and review of registration dossiers as per CTD/ACTD and country. Specific formats.
2. Review quality documents, such as API’s DMF and finished Product Specifications, Certificate of Analysis, BMR, BPR, Process Validation, Stability, etc., for compliance with guidelines.
3. Plan and coordinate with departments, such as QA, QC, and Production, to project the document requirements for appropriate submissions.
4. Coordinate with clients to track and update the status of project plans.
5. Preparation of responses to queries raised by regulatory authorities and clients.
6. Preparation of Product Questionnaire. MAF and all related documents for bidding on international tenders.
7. Literature search/survey to compile clinical and non-clinical parts within registration dossiers.
8. Preparation and review of SPC, Product monograph, package insert and labelling information.
9. Involved in drafting & reviewing applications for Product Approval, CPP, and MMC. Non-Conviction Certificate and FSC
10. Involved in preparing renewal applications for certificates like GMP, CPP, WHO-GMP, GLP, & Non-Conviction Certificates.

How to Apply

Application Process:

• Send your updated resume to hr.gbu@indswiftlabs.com.
• For queries, contact us at +91-7087978441.

Documents to Prepare:

• Updated resume
• Academic and professional certificates
• Government-issued ID proof

Tagged as: Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs