Regulatory Affairs Officer
1 month ago
Identified regulationsrelated toContent of ANDA, Patent and Exclusivity, Prior Approval Supplement (PAS), Changes to ANDA and ICH Q6-A Facilitated in Annual report preparation for several solid oral products Demonstrated Stability data review, BPR review, Validation report reviews and Human prescription drug labelling Preparation of labelling section 1.14 in module 1 of ANDA dossier Facilitated in preparation of several sections of Module 32s & 32p Hands-on experience with eCTD software (PharmaReddy)for SPL generation, registration of new drug product, sequence creation, uploading of modules for eCTD submission Submissions via ESG
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Regulatory Affairs Officer
6 months ago
Ahmedabad, India Swastik Placement Agency Full time**Position : Regulatory Affairs Officer/Executive (Female)** **Education : B Pharm (Preferably)** **Experience : 1-2 Years** **Work Profile**: 1. Preparation & Checking of Dossiers of formulation products for product registration in other countries. 2. Co-ordination with Manufacturer & our partner in country (With their regulatory person) 3. Travel may...
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Regulatory Affairs Officer
2 months ago
Odhav, Ahmedabad, Gujarat, India Nest Healthcare Pvt Ltd Full time**Position**: Regulatory Affairs Specialist **Location**: Odhav. Ahmedabad **Department**: Regulatory Affairs **Reports to**: Regulatory Affairs Manager / Director Job Summary: Key Responsibilities: - **Compliance Monitoring**: Monitor changes in regulations and guidelines to ensure ongoing compliance with local and international regulations. -...
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Regulatory Affairs Officer
5 months ago
Ahmedabad, Gujarat, India Swastik Placement Agency Full time**Position : Regulatory Affairs Officer/Executive (Female)** **Education : B Pharm (Preferably)** **Experience : 1-2 Years** **Work Profile**: 1. Preparation & Checking of Dossiers of formulation products for product registration in other countries. 2. Co-ordination with Manufacturer & our partner in country (With their regulatory person) 3. Travel may...
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Regulatory Affairs Officer
6 months ago
Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full timeHiring for a **REGULATORY AFFAIRS OFFICER ** for our **Ahmedabad **location. Freshers with good knowledge should apply **Key Responsibilities**: - Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies. -...
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Regulatory Affairs Executive
5 months ago
Ahmedabad, India Prime Placement Full timePosition: Regulatory Affairs Assistant - Cosmetic Industry Department: Regulatory Affairs Experience Required: 0-2 years Location: Santej, Ahmedabad Salary Range: 2.2 LPA - 3 LPA Roles & Responsibilities: 1. Handling Legal Documents and Regulatory Affairs: - Assist in the preparation, review, and submission of regulatory documents. - Maintain and...
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Officer - Regulatory Affairs
6 months ago
Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full timeRegulatory affairs executive - B Pharm or M Pharm with 2 years plus experience. **Job description**: - Preparing Dossiers for registration of products in various ROW markets and query response submission - Legalization of FDCA documents for respective country registration - Arrangement of Sample for registration submission from respective team - Prior...
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Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India SWASTIK PLACEMENT AGENCY Full timeRegulatory Affairs ResponsibilitiesAt SWASTIK PLACEMENT AGENCY, we are seeking a skilled Regulatory Affairs Officer to facilitate compliance with regulations and ensure seamless product registration. Key responsibilities include:• Reviewing and analyzing regulations related to ANDA, patent and exclusivity, prior approval supplements, and changes to...
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Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Vyana Consultancy Full timeRegulatory Affairs Role at Vyana ConsultancyVyana Consultancy is seeking a highly skilled Regulatory Affairs professional to join our team. In this role, you will play a critical part in ensuring our organization's products meet the necessary regulatory standards, enabling us to bring safe and effective products to market.Key Responsibilities:Develop...
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Regulatory Affairs Professional
4 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Executive - Regulatory AffairsJob Description:We are seeking a highly skilled and experienced Regulatory Affairs Professional to join our team at Ikamate HR India Pvt. As an Executive - Regulatory Affairs, you will be responsible for preparing and reviewing dossiers in ACTD, CTD or country-specific formats for the ROW market. You will also be...
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Regulatory Affairs Specialist
4 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the JobWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Preparation of dossiers as per the ACTD CTD (Module I II III IV and V)...
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Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. The successful candidate will be responsible for preparing and reviewing dossiers in various formats, coordinating with QA/QC departments, and ensuring compliance with regulatory...
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Ahmedabad, Gujarat, India Lifelancer Full timeAbout the RoleWe are seeking a skilled Regulatory Affairs Officer to join our team at Lifelancer. The ideal candidate will have hands-on experience with eCTD software, be proficient in Annual report preparation, and possess knowledge of regulatory requirements.Key Responsibilities:Facilitate Annual report preparation for various solid oral productsReview...
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Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the JobSkills: Regulatory, Compliance, Regulatory Affairs, Regulatory Documentation, Regulatory Submissions, Regulatory Reporting, ICH-GCPJob Overview:This is a Full-Time position in Ahmedabad, requiring 4-6 years of experience.Key Qualifications and Skills:Regulatory affairs experience within the pharmaceutical sectorKnowledge of regulatory frameworks...
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Regulatory Affairs Officer
2 months ago
Sola, Ahmedabad, Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full timeWe are urgently looking for **Regulatory Affairs Executive.** Age criteria: below 30 Qualification - B.pharm/M.pharm Experience: 0 to 2 years only Location: Sola, Ahmedabad Work mode: on site **Job role: -** ➤ Should have worked in Regulated Market (ROW). ➤ Dossier Submission, Dossier preparation (ACTD & CTD). ➤ Technical Documents...
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Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Preparation of dossiers as per ACTD CTD (Module I II III IV and V) guidelines.Technical document...
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Regulatory Affairs Officer
2 weeks ago
Sola, Ahmedabad, Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full time**We are urgently looking for Regulatory Affairs Executive.** Age criteria: below 30 Qualification - B.pharm/M.pharm Experience: 0 to 2 years only Location: Sola, Ahmedabad Work mode: on site Job role: - ➤ Should have worked in Regulated Market (ROW). ➤ Dossier Submission, Dossier preparation (ACTD & CTD). ➤ Technical Documents review. ➤...
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Regulatory Affairs Specialist
4 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeJob Title: Executive - Regulatory AffairsJob Description:We are seeking a skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. The ideal candidate will have experience in preparing and reviewing dossiers, as well as coordinating with QA/QC departments and regulatory authorities.Key Responsibilities:Preparation and review of...
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Regulatory Affairs Executive
6 months ago
Science City, Ahmedabad, Gujarat, India Vetenza India Pvt Ltd. Full timeHiring for a **REGULATORY AFFAIRS EXECUTIVE** for our **Ahmedabad **location. **Key Responsibilities**: - Assist in the preparation, compilation, and submission of regulatory documents, such as drug master files (DMFs), technical dossiers, and regulatory filings, to health authorities and regulatory agencies. - Maintain and update regulatory documentation...
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Regulatory Affairs Specialist
3 weeks ago
Ahmedabad, Gujarat, India Ikamate HR India Pvt Full timeRegulatory Affairs RoleAs a Regulatory Affairs Specialist at Ikamate HR India Pvt, you will be responsible for preparing and reviewing dossiers in compliance with ACTD, CTD, or country-specific formats for global markets. This includes coordinating with QA/QC departments for technical and legal documents, preparing artwork for registration, and managing...
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Regulatory Affairs Executive
3 weeks ago
Ahmedabad, Gujarat, India Lifelancer Full timeJob SummaryWe are seeking an experienced Regulatory Affairs Executive to join our team at Lifelancer, a leading platform connecting talent with opportunities in Life Sciences, Pharma, and IT.ResponsibilitiesPrepare dossier submissions as per the ACTD CTD (Module I II III IV and V) guidelines.Develop and review technical documents, including raw material and...