RA Formulation & Development Domestic Market

Job Purpose:

To lead and support formulation development activities for solid and liquid dosage forms, including nutraceuticals, ensuring regulatory compliance and robust documentation for domestic submissions.

Key Responsibilities:

1. Formulation Development:

• Design and develop solid (tablets, capsules) and liquid (syrups, suspensions) dosage forms.
• Conduct pre-formulation studies, prototype development, and scale-up trials.
• Optimize formulations for stability, bioavailability, and manufacturability.

2. Nutraceutical Expertise:

• Develop innovative nutraceutical formulations aligned with market trends and therapeutic needs.
• Evaluate functional ingredients, excipients, and delivery systems for efficacy and safety.

3. Regulatory Compliance:

• Prepare and review technical documentation for domestic regulatory submissions (FSSAI, CDSCO, etc.).
• Ensure adherence to regulatory guidelines and pharmacopeial standards.

4. Stability Studies:

• Design and execute stability protocols as per ICH guidelines.
• Analyze stability data and prepare reports for product registration and shelf-life determination.

5. Technology Transfer:

• Support scale-up and technology transfer to manufacturing units.
• Collaborate with cross-functional teams including QA, QC, RA, and Production.

6. Documentation & Reporting:

• Maintain comprehensive records of formulation trials, batch manufacturing records, and development reports.
• Prepare product development reports and dossiers for internal and external audits.

Desired Candidate Profile:

• Education:

  M.Pharm in Pharmaceutics or related field

• Experience:

  1-2 years in formulation development for domestic market

• Skills:

• Hands-on experience in solid and liquid dosage forms
• Knowledge of nutraceuticals and functional ingredients
• Familiarity with domestic regulatory frameworks
• Proficiency in stability study design and documentation
• Strong analytical and problem-solving skills

Preferred candidate profile