Position Title

Manager - Formulation Development (Topical & Semisolid Products Regulated Markets)

Dosage Forms

Topical Emulgel, Gel, Cream, Lotion, Ointment & Spray

Department

Research & Development - Formulation Development

Reporting To

Head / Senior Manager - Formulation Development

Location

Hyderabad, Telangana

Education

M.Pharm (Pharmaceutics) / B.Pharm

Experience

8-15 years of pharmaceutical formulation development experience

Experience in regulated-market product development (US/EU) is preferred.

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Job Summary

The Manager Formulation Development (Topical Products) will independently lead the development of complex and generic topical pharmaceutical products including gels, creams, lotions, ointments, emulsions, solutions, suspensions, foams, and sprays for regulated markets (US FDA, EMA, UK, Canada, Australia, and other global markets).

The role requires solid expertise in QbD-driven formulation development, QTPP definition, Q1/Q2/Q3 formulation optimization, IVRT/IVPT strategy, bioequivalence (BE) assessment, PK/PD understanding, regulatory submission support, scale-up, and commercialization.





The candidate will be responsible for developing robust, bioequivalent, and clinically relevant topical formulations that align with current regulatory expectations for complex dermatological products.

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Required expertise

- Topical semisolid formulations
- Gel, cream, lotion, ointment, spray development
- US FDA/EMA regulated products
- Q1/Q2/Q3-based formulation development
- IVRT/IVPT studies
- BE strategy for topical products
- QbD implementation
- Scale-up and technology transfer

Key Responsibilities

1. Regulated Market Topical Product Development Strategy
2. QbD-Based Formulation Development
3. Q1/Q2/Q3-Based Topical Formulation Development
4. Topical Dosage Form Development Expertise
5. IVRT & IVPT Strategy Development
6. Bioequivalence (BE) Strategy & PK Understanding
7. Preformulation & Product Characterization
8. Scale-Up & Technology Transfer
9. Stability & Regulatory Documentation
10. Team & Project Management

📌 Manager F&D Topical & Semisolid Products Regulated Markets (Hyderabad)
🏢 MAKSON GROUP
📍 Hyderabad