Regulatory Affairs Executive

2 weeks ago

Bodakdev Ahmedabad Gujarat, India Unicor Pharma Full time

**Roles & Responsibilities: -**

1. Prepare and submit regulatory dossiers for new product registrations, variations, and renewals for Tablets, Capsules, Liquids, Ointments and Powders for Africa, CIS and LATAM countries.

3. Facilitate communication with health authorities, responding to queries, and ensuring compliance with regulatory timelines.

4. Ensure that all pharmaceutical products comply with regulatory requirements in target markets.

5. To ensure all the compliances before any regulatory audit and to represent the company during the regulatory audits.

6. Review product labeling, packaging, and advertising materials to ensure compliance with regulatory guidelines.

7. Maintain accurate and comprehensive regulatory files and documentation for products in compliance with regional regulations.

8. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in target regions.

9. Identify regulatory pathways for new product launches and lifecycle management of existing products.

10. Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure that the products meet regulatory requirements throughout the product development lifecycle.

11. Collaborate with marketing and sales teams to ensure that product claims and promotional activities align with local regulatory requirements.

12. Continuously track and evaluate changes in drug regulations, including GMP (Good Manufacturing Practice) and other relevant policies across various target countries.

13. Build and maintain strong relationships with key regulatory authorities in various target regions, including ministries of health, regulatory bodies, and industry associations.

14. Represent the company at regulatory meetings, conferences, and workshops related to pharmaceutical regulations.

**Education, Experience and Skills Required:

- **

2. 1 year of experience in Regulatory Affairs in Pharmaceutical Formulations unit desired.
3. Excellent communication skills.

**Salary - 20,000 - 25,000 per month (CTC)**

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Provident Fund

Schedule:

- Day shift

Work Location: In person

  • Regulatory Affairs Executive

    1 day ago

    Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full time

    Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience in similar profile or work area. **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...

  • Regulatory Affairs Executive

    2 weeks ago

    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. -...

  • Regulatory Affairs Executive

    2 weeks ago

    Sola, Ahmedabad, Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full time

    **West coast pharma is looking for Regulatory Affairs Head - Male preferred** Qualification: B.PHARM/M.PHARM Experience: 5 to 10 years only **Regulatory Affairs Head - Pharmaceuticals Job Role**: The Regulatory Affairs Head leads the regulatory strategy and compliance for pharmaceutical products. They oversee submission of dossiers to health authorities,...

  • Regulatory Affairs Executive

    2 weeks ago

    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 Executive

    1 week ago

    Vadodara, Gujarat, India Ronak Group Full time

    Looking for an Enthusiastic, Efficient & Trustworthy Senior Executive - Regulatory Affairs for a Leading MNC “**Ronak Group”** **Company: Ronak Group (MNC)** Position**:Executive / Senior Executive - Regulatory Affairs** Experience: 2 to 7 Years Location: Vadodara, India We are looking for Energetic & Goal Oriented **Executive / Senior Executive -...

  • Regulatory Affairs Executive

    2 weeks ago

    Sachin, Surat, Gujarat, India Globela Pharma Pvt. Ltd. Full time

    **Job Description: Regulatory Affairs Executive (Fresher to 3 Years Experience)** **Position**: Regulatory Affairs Executive **Department**: Regulatory Affairs **#### **Key Responsibilities**: - **Regulatory Submissions**: - Prepare and submit regulatory documents to health authorities (FDA, EMA, TGA, etc.) for new products, amendments, and...

  • Executive - Regulatory Affairs

    1 week ago

    Ahmedabad, Gujarat, India Contract Pharmacal Corp. Full time

    Responsibilities include, but are not limited to: - Review/approve Master Carton Labels, Pallet Labels, Blister Master Proofs and Printer proofs. - Support and Prepare draft Ingredient Lists. - Support Label Claim Substantiation activities. - Support drug product listing and maintenance, as needed. - Support second sourcing projects, as needed. - Prepare,...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Winston HR Services,Ahmedabad Full time

    POSITION :REGULATORY AFFAIRS EXPERIENCE : 0 TO 1 QUALIFICATION : B.PHARM, M.PHARM. JOB LOCATION : AHMEDABAD mo: 7383005000 SHIVANI WINSTON HR SERVICES **Salary**: ₹15,000.00 - ₹20,000.00 per month Schedule: - Day shift **Experience**: - total work: 1 year (preferred) Ability to Commute: - Ahmedabad, Gujarat (required) Ability to...

  • Regulatory Affairs Assistant

    2 weeks ago

    Jarod, Vadodara, Gujarat, India Briyosis Soft Caps Pvt Ltd Full time

    **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 annually. Our...

  • Regulatory Affairs Executive

    1 day ago

    Ahmadabad, Gujarat, India Aegis Lifesciences Pvt Ltd Full time

    Title/Designation: Executive - Regulatory Affairs Reports to: RA Manager Based at: Ahmedabad Industry: class III Medical Device Qualification : B.pharm, M.pharm or Msc Job description An exciting opportunity to work for class III / Class -D medical device certification & regulations Key responsibilities/ accountabilities: For the above position, your...