International Regulatory Affairs Executive
4 days ago
JOB PROFILE POSITION: EXECUTIVE - INTERNATIONAL REGULATORY AFFAIRS LOCATION: Gota, SG Highway, Ahmedabad
QUALIFICATIONS: B-Pharm / M-Pharm
EXPERIENCE: Minimum: 01 to 02 Years RESPONSIBILITIES:
- Preparing, Reviewing and Submitting - Product Dossiers as per Country Specific guidelines
- Preparing, Reviewing and Submitting - Renewal Dossiers / Variations.
- Responding to queries raised by Regulatory authority of respective country.
- Preparing CAPA reports for the audit or market complaints.
- Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc.
- Coordinating & Arranging for the registration samples as per country guideline.
- Reviewing & Approving the Artworks (Text Content)
- Coordinating with FDCA Person for COPP & GMP and its legalization process.
- Updating all registration status records.
- Maintaining Retain Samples Records.
- Coordinating with customer for filing of dossier & getting it timely approval.
SKILLS:
Fluent in English.
Good communication skills.
Ability to work under pressure and to meet deadlines.
**Job Types**: Full-time, Permanent
Pay: ₹12,155.03 - ₹49,054.27 per month
**Benefits**:
- Paid sick time
- Paid time off
Work Location: In person
-
Regulatory Affairs Executive
5 days ago
Gota, Ahmedabad, Gujarat, India Noronic Pharmaceutical Pvt Ltd Full timeJob Title: Regulatory Affairs Specialist Department: Regulatory Affairs Location: HO Office, Gota Ahmedabad Company name : Noronic pharmaceutical Job Summary: The Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory requirements, overseeing the preparation of technical documents, and supporting product registration and...
-
International Regulatory Affairs Executive
2 weeks ago
Gota, Ahmedabad, Gujarat, India Surety Healthcare LLP Full time ₹ 3,00,000 - ₹ 6,00,000 per yearJOB PROFILE POSITION: EXECUTIVE – INTERNATIONAL REGULATORY AFFAIRS LOCATION: Gota, SG Highway, AhmedabadQUALIFICATIONS: B-Pharm / M-PharmEXPERIENCE: Minimum: 01 to 02 Years RESPONSIBILITIES:Preparing, Reviewing and Submitting – Product Dossiers as per Country Specific guidelinesPreparing, Reviewing and Submitting – Renewal Dossiers /...
-
Regulatory Affairs Executive
6 days ago
Ahmedabad, Gujarat, India, Gujarat BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
-
Regulatory Affairs Intern
7 days ago
Prahlad Nagar, Ahmedabad, Gujarat, India Maven Profcon Services LLP Full timeJob Description: As a **Medical Device Regulatory Affairs Intern**, you will work alongside experienced regulatory professionals, gaining hands-on experience in regulatory submissions, compliance research, and documentation for medical devices. Key Responsibilities: - Assist in preparing regulatory documentation for product registrations and submissions. -...
-
Regulatory Affairs Executive
2 weeks ago
Navrangpura, Ahmedabad, Gujarat, India Bexcode Services Full time**Regulatory Affairs Executive Job Description** **Job Summary**: The Regulatory Affairs Executive will work with product development and manufacturing management to ensure that the product development process meets all applicable regulatory requirements. **Duties/Responsibilities**: - Works in the regulatory affairs department on assigned projects. -...
-
Regulatory Affairs Executive
5 days ago
Jagatpur, Ahmedabad, Gujarat, India Pharmaceutical Distributor Full time**Introduction**: We are seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz,...
-
Regulatory Affairs Executive
1 week ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
-
Regulatory Affairs Executive
1 week ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
-
Regulatory Affairs Executive
1 week ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...
-
Regulatory Affairs Executive
1 week ago
Ahmedabad, India BKM Health Pvt Ltd Full timeRegulatory Affairs Executive :(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like...