Senior Executive -Global Regulatory Deficiency Centre

Aarti Pharmalabs; Navi Mumbai; On-site; INR 1,100,000 - 1,800,000; Full time

Job summary

Aarti Pharmalabs in Navi Mumbai, India, seeks an experienced professional for API process development and optimization, technology transfer to pilot/production, and regulatory support to ensure DMF readiness.

The role requires an MSc or PhD in Organic Chemistry with 2–8 years of relevant experience, strong cross-functional coordination with RA, ADL, and DQA teams, and meticulous attention to CPPs, CQAs, and material specs.

Qualifications

• M.Sc. (Organic Chemistry) or Ph.D. (Organic Chemistry) required.
• 2 to 8 years of relevant experience.

Responsibilities

• API Process Development & Optimization: feasibility studies, process optimization, scale-up, CPPs/CQAs identification, plan lab work, RS/WS preparation, tech transfer initiation.
• Regulatory Affairs & Compliance Support: provide technical support for regulatory queries, DMF preparation, prepare spec sheets and MSDS, develop Development History Report and carry out stability studies.
• Cross-Functional Coordination: coordinate with RA, ADL, IPR and DQA teams, manage coordination with R&D officers.

Skills

Process development

Technology transfer

Regulatory coordination

Cross-functional teamwork

Education

M.Sc. Organic Chemistry

PhD Organic Chemistry

Job description

Role & responsibilities

Key Responsibilities:

API Process Development & Optimization:

• Perform feasibility studies, process optimization, and scale-up of API processes. Conduct process verification and identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
• Plan lab work, prepare Reference Standards (RS)/Working Standards (WS), and ensure their characterization.
• Initiate the technology transfer process to the pilot plant or production facility.

Regulatory Affairs & Compliance Support:

• Provide timely technical support for regulatory queries, especially those related to DMF preparation.
• Ensure accurate preparation of specification sheets and MSDS for raw materials and intermediates.
• Prepare the Development History Report for regulatory submission and archival. Conduct initial stability studies for developed products.

Cross-Functional Coordination:

• Coordinate with the Regulatory Affairs (RA), Analytical Development Lab (ADL), IPR, and Development Quality Assurance (DQA) teams.
• Manage coordination between officers working in R&D.

Required Qualifications & Experience:

• Education: M.Sc. (Organic Chemistry) or Ph.D. (Organic Chemistry) Experience: 2 to 8 years of relevant experience