Job Summary

We are seeking an experienced Formulation Development Executive with a strong background in Liquid Orals and Nasal dosage forms to join our R&D; team. The ideal candidate will have hands-on experience in developing formulations for regulated markets such as the EU and Brazil (ANVISA), and will be responsible for driving product development from concept through technology transfer, ensuring compliance with applicable regulatory guidelines.

Key Responsibilities

- Design, develop, and optimize formulations for Liquid Oral and Nasal dosage forms in line with target product profiles (TPP) and Quality Target Product Profiles

(QTPP).
- Conduct pre-formulation studies, including drug-excipient compatibility,

solubility, and stability assessments.
- Execute formulation trials at lab scale and scale-up batches, ensuring reproducibility and robustness of the process.
- Prepare and review Batch Manufacturing Records (BMRs), development reports,

and technology transfer documents.
- Ensure formulations comply with EU (EMA) and Brazil (ANVISA) regulatory requirements, including relevant guidelines on excipients, container closure systems, and impurity profiles.
- Coordinate with Analytical Development (AR&D;), Regulatory Affairs, Quality

Assurance, and Packaging Development teams for seamless product development.
- Support technology transfer to manufacturing sites,



including process validation and scale-up activities.
- Handle stability studies (accelerated and long-term) as per ICH guidelines and review stability data for regulatory submissions.
- Troubleshoot formulation and process-related issues during development and manufacturing scale-up.
- Maintain proper documentation as per GLP/GMP and data integrity requirements.
- Stay updated with regulatory guidelines, compendial requirements (USP/EP/BP),

and industry trends relevant to liquid orals and nasal products.
- Support preparation of regulatory dossiers (CTD/eCTD format) with technical inputs for EU and Brazil submissions.

Required Qualifications & Skills
- Education: M.Pharm (Pharmaceutics or related field)
- Experience: Minimum 5 years of hands-on formulation development experience in Liquid Orals and Nasal dosage forms, specifically for regulated markets (EU /

Brazil).
- Strong understanding of dosage form-specific challenges — preservative efficacy (liquid orals), and device compatibility (nasal sprays/pumps).
- Working knowledge of regulatory requirements for EU (EMA) and Brazil (ANVISA)

markets.
- Good understanding of ICH stability guidelines, QbD principles, and risk assessment tools (FMEA).
- Strong documentation, analytical thinking, and problem-solving skills.
- Positive communication and cross-functional collaboration skills.

📌 Formulation-Nasal Spray (Ulhasnagar)
🏢 Athena Pharmaceutiques
📍 Ulhasnagar