Regulatory Affairs Executive
6 days ago
**Position**: Regulatory Affairs - Senior & Junior
**Qualification**: B.Pharm / M.Pharm
**Experience**: 3-4 years in the same department
**Openings**: 1 Senior, 2 Junior
**Salary Range**: ₹30,000 - ₹50,000 per month (based on experience)
**Location**: Ahmedabad
**Key Responsibilities**:
- Review dossiers prepared by executives/trainees and submit to clients along with artworks for markets such as Asia, LATAM & ROW.
- Handle renewals of Registration Certificates for various countries.
- Ensure compliance of products with current ICH and country-specific guidelines.
- Arrange and courier legalized documents (COPP, FSC, POA, Manufacturing Agreements, Declaration letters, GMP certificates) to clients/countries.
- Coordinate the courier of samples for new registrations and renewals for reanalysis and commercial batch testing.
- Arrange required samples and legal documents from Legal, Production, and FRD teams.
- Follow up with FRD and Microbiology departments for client-specific testing requirements.
- Arrange and dispatch Working Standards from QC to clients/countries for testing purposes.
- Resolve client queries related to new registrations and renewals in accordance with country requirements.
- Maintain country-specific global status sheets for new registrations, renewals, and query status.
- Coordinate with the Artwork department for review and corrections of artworks for new registrations and renewals.
- Follow up and arrange documents for dossier preparation from QA, QC, ARD, and Microbiology departments as per guidelines.
**Desired Skills**:
- Strong knowledge of regulatory documentation and country-specific guidelines.
- Excellent coordination, follow-up, and communication skills.
Detail-oriented with the ability to handle multiple projects simultaneously.
**With Regards,**
**Himani(HR)**
**9377165778**
**Job Types**: Full-time, Permanent
Pay: ₹25,000.00 - ₹50,000.00 per month
Work Location: In person
-
Regulatory Affairs Executive
1 week 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
6 days ago
Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time**Job Summary**: The Regulatory Affairs Executive will be responsible for preparing, reviewing, and submitting regulatory dossiers for nutraceutical products intended for Rest of the World (RoW) markets. The role ensures compliance with country-specific requirements and involves coordination with internal teams, distributors, and regulatory agents for timely...
-
Regulatory Affairs Executive
1 week 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
4 days 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...
-
Executive Regulatory Affairs
4 days ago
Ahmedabad, India Nexus Corporate Solution Pvt. ltd. Full timeHello Professional, Greeting from Nexus..!! We are urgently looking for Executive Regulatory Affairs for one of the Pharmaceutical Manufacturing Industry at Ahmedabad. Experience: - 1 Years Qualification: - Graduate. Job Description: - Should be prepare & compile registration dossier of ACTD, CTD & Regional as per the guidelines and checklist for...
-
Regulatory Affairs Injectable
2 weeks ago
Ahmedabad, Gujarat, India Resonacle Full timeRegulatory Affairs Pre-Approval - Injectable & Complex Injectables Executive / Senior Executive / Assistant Manager / Deputy Manager / Manager Experience: 03-10 Years Budget: 05-25 LPA ANDA Filling exposure for USA Market for Injectable and Complex Injectable products. Pre-Approval experience required.
-
Regulatory Affairs
5 days ago
Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWe are hiring Regulatory Affairs (RA) Executive / Manager for a leading Pharma company in Ahmedabad. The candidate will be responsible for dossier preparation, product registration, regulatory submissions, and maintaining compliance with international guidelines (ROW / LATAM / Africa). Must have hands-on experience in RA documentation for pharma...
-
Regulatory Affairs Executive
2 weeks ago
Sola, Ahmedabad, Gujarat, India DF Pharmacy Full time**Job Role: Regulatory Affairs (RA) Head (Male preferred)** **Responsibilities**: - Oversee regulatory submissions, compliance, and approvals for products. - Ensure adherence to international and local regulatory requirements. - Develop and implement regulatory strategies to support business objectives. - Lead communication with regulatory authorities and...
-
Regulatory Affairs Assistant
4 days ago
Jarod, Vadodara, Gujarat, India Briyosis Soft Caps Pvt Ltd Full timeJob description **Company Description** Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels...
-
Regulatory Affairs Executive
5 days ago
Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per yearNutralike is a leading nutraceutical manufacturer offering premium-quality products across tablets, capsules, powders, and syrups. With global compliance standards and presence across ROW, Middle East, EU, CIS, and GCC markets, Nutralike focuses on innovation, safety, and quality. Learn more at Job Summary:The Regulatory Affairs Executive will be...