Regulatory Operations Expert

Job Title

Regulatory Operations Expert

Job Location

Mumbai

Job Location Type

Remote

Job Contract Type

Full-time

Job Seniority Level

Job Overview

Scientific Writer with strong expertise in material science, analytical chemistry, and chemical principles (organic and inorganic) as applied to pharmaceutical formulation, manufacturing, and product lifecycle management.

This role serves as a scientific authority for translating material, analytical, and process knowledge into robust, lifecycle ready CMC documentation. The position is a key enabler of knowledge capture, scientific consistency, and regulatory defensibility across technology transfer, PPQ, and commercial manufacturing.

You work at the interface of science, manufacturing, quality, and regulatory, ensuring that how we understand materials and processes is clearly articulated, justified, and sustained throughout the product lifecycle

Summary of Responsibilities

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual contributor globally.

Scientific Leadership & CMC Knowledge Translation

Act as a scientific owner for the development of high‑quality CMC documentation related to

Pharmaceutical raw materials and excipients

Process aids and contact materials (incl. leachables & extractables)

Material changes, supplier changes, and lifecycle optimization activities

Translate complex analytical, chemical, and manufacturing data into

Scientifically rigorous justifications

Risk assessments and material qualification reports

CMC sections supporting variations, supplements, and regulatory responses

Ensure scientific content is aligned with Quality‑by‑Design principles and clearly supports

Control strategies

Defined design space and material attribute justifications

Lifecycle change management

Analytical Chemistry & Chemical Understanding

Integrate and critically interpret analytical chemistry data, including

Physicochemical characterization

Impurity and degradation profiles

Elemental and inorganic contaminants

Comparability and trend analyses

Apply organic and inorganic chemistry principles to

Assess material composition, chemical reactivity, and degradation pathways

Evaluate compatibility with formulations, processes, and packaging systems

Support scientifically sound impurity and risk justifications

Identify analytical data gaps and define scientifically appropriate strategies to close them, in collaboration with analytical development and external laboratories.

Manufacturing Processes, Unit Operations & MSAT Lifecycle Support

Provide scientific assessments on the impact of material attributes on pharmaceutical manufacturing processes and unit operations, including

Blending, granulation, drying, compression, coating

Mixing, filtration, emulsification, sterilization (as applicable)

Support technology transfer, PPQ, and commercial manufacturing by

Documenting material‑process interactions

Supporting root cause investigations and comparability assessments

Providing scientific rationales for process or material changes

Ensure scientific conclusions reflect manufacturing reality, robustness, and process capability, not only laboratory observations.

Lifecycle Management, Compliance & Regulatory Alignment

Ensure documentation is fully aligned with global regulatory and compliance expectations, including

ICH Q8–Q12 principles

Pharmacopeial requirements

GMP expectations for materials, suppliers, and change management

Support regulatory submissions, variations, and health authority interactions by

Providing clear, defensible scientific rationales

Ensuring consistency between analytical data, process understanding, and CMC narratives

Maintain strong traceability between experimental data, conclusions, and regulatory positions throughout the product lifecycle.

Cross‑Functional Scientific Collaboration

Act as a scientific interface between MSAT, Analytical Development, Formulation, Manufacturing, Quality, and Regulatory Affairs.

Engage with external suppliers, contract laboratories, and technical experts to

Clarify chemistry‑ and material‑related questions

Challenge data quality where needed

Ensure completeness and scientific credibility of external information

Contribute actively to knowledge management within MSAT by ensuring scientific learnings are captured in a reusable, lifecycle‑oriented manner.

Qualifications (Minimum Required)

Bachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable. “Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.” OR

Advanced degree (MSc or PhD) in: Chemistry (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences

Innovation and Proactive, taking ownership, Precise, Goal oriented.

Leadership, problem solving, interpersonal skills.

Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.

Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable Years of experience in the job discipline.

Good organizational and time management ability

Good analytical capabilities and Customer focus

Good review skills and concern for quality

Capabilities to face internal and external Audit situation

Excellent command of written and spoken English and/or other languages as applicable

Experience (Minimum Required)

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 a