International Regulatory Affairs Executive

7 days ago


Makarba Ahmedabad Gujarat, India Tashi Pharma Full time

**JOB PROFILE**

POSITION:_**EXECUTIVE - INTERNATIONAL REGULATORY AFFAIRS**_

OFFICE TIME: 9:30 AM to 6:30 PM (Monday to Friday)

On Saturday’s (i.e. 1st / 3rd, 5th Working till 04:00 PM)

On Saturday (i.e. 02nd & 4th having off)

LOCATION: Makarba, SG Highway, Ahmedabad

QUALIFICATIONS: B-Pharm / M-Pharm

EXPERIENCE: Minimum: 01 to 02 Years
- 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.

Fluent in English.

Good communication skills.

Ability to work under pressure and to meet deadlines.

Pay: ₹25,000.00 - ₹35,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Paid sick time
- Paid time off

Supplemental Pay:

- Yearly bonus

Application Question(s):

- Are you from Pharma Industry ?
- Have you done B Pharm or M Pharm ?

**Language**:

- English (preferred)

Work Location: In person



  • 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...


  • 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. -...


  • Ahmedabad, Gujarat, India DF Pharmacy Full time

    **Job Posting: Regulatory Affairs Executive** **Location**: Sola, Ahmedabad **Salary**: ₹10,000 - ₹20,000 per month **Key Responsibilities**: - Prepare, review, and submit regulatory documents (e.g., dossiers, DMFs) to regulatory authorities. - Coordinate with R&D, QA, and production teams to gather necessary documentation for product registration. -...


  • 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,...


  • Ahmedabad, Gujarat, India CLAPS Industries Private Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Company DescriptionCLAPS Industries Pvt Ltd. is a global pharmaceutical company that was founded by a visionary team of highly successful individuals in the field of pharmaceuticals. The company is dedicated to providing high-quality healthcare products and services globally. CLAPS is expanding rapidly through product diversification, strategic...


  • Ahmedabad, Gujarat, India Angiplast Private Limited Full time

    “Job Description” **Position**:Regulatory Affairs - Executive Cum Microbiologist** **Department: Regulatory Affairs / Microbiologist** **Min Qualification: B.Pharm, M.pharm,Bio-Medical Engineer, B.Sc or M.sc with Microbiology** **Min Experience: 3 - 5 Years** **SAARY**: 30,000 To 60,000 **Industries Preferred: Medical Device / Pharma / Bio-Tech /...

  • Regulatory Affairs

    7 days ago


    Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    We 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...


  • Ahmedabad, India Prime Placement Full time

    Position: 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...


  • 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...


  • Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time ₹ 4,00,000 - ₹ 8,00,000 per year

    Nutralike 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...