Regulatory Operations Expert
On-siteMumbai, Maharashtra, India
Job Summary
Develop high-quality CMC documentation for pharmaceutical raw materials, excipients, and process aids by translating complex analytical and chemical data into scientifically rigorous justifications and risk assessments. Integrate physicochemical characterization, impurity profiles, and degradation pathways to support control strategies, design space definitions, and lifecycle change management aligned with ICH Q8–Q12 principles. Provide scientific assessments on material attributes impacting unit operations such as blending, granulation, and sterilization while supporting technology transfer, PPQ, and commercial manufacturing. Serve as a scientific interface between MSAT, analytical development, formulation, and regulatory affairs to ensure global regulatory compliance and defensible narratives for regulatory submissions.
Required Qualifications
- Bachelor's in Pharmacy or related science degree (or equivalent)
- Advanced Degree (e.g., PhD or Masters) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences
- At least 7-9 years of experience in the job discipline (e.g. Regulatory Affairs/Quality Assurance/Analytical Science / Packaging, polymer and/or Pharmaceutics / material management, Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences and overall drug development and manufacturing process
- Minimum 1+ year of experience in project management is desirable
- Strong, hands on scientific understanding of: Analytical chemistry and material characterization
- Organic and inorganic chemistry relevant to pharmaceutical materials
- Pharmaceutical manufacturing processes and unit operations
- Demonstrated experience in CMC relevant scientific documentation, including: Material qualification and risk assessments
- Comparability and lifecycle justifications
- Regulatory facing scientific narratives
- Ability to independently analyze complex datasets, draw defensible conclusions, and clearly articulate scientific rationale
- Familiar with pharmaceutical compliance, including GMP expectations for materials, suppliers, and lifecycle change control
- Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location
- Regular and consistent attendance
- Varied hours may be required
Desired Qualifications
- Bachelor's in pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) with 7-9 years of relevant experience
- Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences
- Knowledge of Management Information System (MIS) and electronic data management system (eg: Regulatory Information Management, etc) system will be preferred
- Diploma or Certification in Regulatory Affairs will be preferred
- Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable
- Good organizational and time management ability
- Good analytical capabilities and Customer focus
- Good review skills and concern for quality
- Scientist mindset with a strong sense of ownership and accountability for scientific quality
- Analytical, structured, and rigorous in data interpretation and verification
- Proactive and confident in engaging senior scientific, manufacturing, and regulatory stakeholders
- Strong communicator who can convert complex science into globally aligned, regulator ready CMC knowledge
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