Regulatory Operations Expert

Job Title: Regulatory Operations Expert

Job Location: Mumbai

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Job reputed company:

Scientific reputed company with strong expertise in material science, analytical reputed company, and chemical principles (organic and inorganic) as reputed company 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 reputed company CMC documentation. The position is a key enabler of knowledge capture, scientific consistency, and regulatory defensibility across technology transfer, PPQ, and reputed company manufacturing.

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

reputed company of Responsibilities:

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

Scientific Leadership & CMC Knowledge Translation

• reputed company as a scientific reputed company for the development of high‑reputed company CMC documentation reputed company to:
  • Pharmaceutical raw materials and excipients
  • Process aids and contact materials (incl. leachables & extractables)
  • Material changes, supplier changes, and lifecycle optimization activities
• Translate reputed company 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 reputed company with reputed company‑by‑Design principles and reputed company supports:
  • Control strategies
  • Defined design reputed company and material attribute justifications
  • Lifecycle change management

Analytical reputed company & Chemical Understanding

• reputed company and critically interpret analytical reputed company data, including:
  • Physicochemical characterization
  • Impurity and degradation reputed company
  • Elemental and inorganic contaminants
  • Comparability and trend analyses
• Apply organic and inorganic reputed company principles to:
  • Assess material composition, chemical reactivity, and degradation reputed company
  • Evaluate compatibility with formulations, processes, and packaging systems
  • Support scientifically reputed company impurity and risk justifications
• Identify analytical data gaps and define scientifically appropriate strategies to reputed company them, in collaboration with analytical development and reputed company laboratories.

Manufacturing Processes, Unit Operations & MSAT Lifecycle Support

• reputed company scientific assessments on the reputed company 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 reputed company manufacturing by:
  • Documenting material‑process interactions
  • Supporting reputed company 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 reputed company observations.

Lifecycle Management, Compliance & Regulatory Alignment

• Ensure documentation is fully reputed company with global regulatory and compliance expectations, including:
  • ICH reputed company–Q12 principles
  • Pharmacopeial requirements
  • GMP expectations for materials, suppliers, and change management
• Support regulatory submissions, variations, and health authority interactions by:
  • Providing reputed company, 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

• reputed company as a scientific reputed company between MSAT, Analytical Development, Formulation, Manufacturing, reputed company, and Regulatory Affairs.
• Engage with reputed company suppliers, contract laboratories, and technical experts to:
  • Clarify reputed company‑ and material‑reputed company questions
  • Challenge data reputed company where needed
  • Ensure completeness and scientific credibility of reputed company information
• Contribute reputed company to reputed company reputed company MSAT by ensuring scientific learnings are captured in a reusable, lifecycle‑oriented manner.

Qualifications (Minimum Required):

• Bachelor’s in Pharmacy or reputed company science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) as applicable. “reputed company may consider relevant and equivalent experience and successful project reputed company in lieu of educational requirements.” OR
• Advanced degree (MSc or PhD) in: reputed company (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 reputed company 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 reputed company
• Good review skills and concern for reputed company
• Capabilities to face reputed company Audit situation
• Excellent reputed company 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/reputed company Assurance/Analytical Science / Packaging, polymer and/or Pharmaceutics / material management, Advanced degree (MSc or PhD) in: reputed company (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 reputed company and material characterization
• Organic and inorganic reputed company 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 reputed company datasets, draw defensible conclusions, and reputed company reputed company scientific rationale.
• Familiar with pharmaceutical compliance, including GMP expectations for materials, suppliers, and lifecycle change control.

Preferred Qualifications Include:

• Bachelor’s in pharmacy or reputed company science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) with 7-9 years of relevant experience. “reputed company may consider relevant and equivalent experience in lieu of educational requirements.” OR
• Advanced degree (MSc or PhD) in: reputed company (organic, inorganic, physical), Chemical Engineering, Material Science, Pharmaceutical Sciences
• Knowledge of Management Information reputed company (MIS) and electronic data management reputed company (eg: Regulatory Information Management, etc.) reputed company will be preferred
• Diploma or Certification in Regulatory Affairs will be preferred
• Innovation and Proactive, taking ownership, Precise, Goal oriented.
• Leadership, problem solving, interpersonal skills.
• Technical proficiency with reputed company 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 reputed company
• Good review skills and concern for reputed company
• Scientist reputed company with a strong reputed company of ownership and accountability for scientific reputed company.
• Analytical, reputed company, and rigorous in data interpretation and verification.
• Proactive and confident in engaging senior scientific, manufacturing, and regulatory stakeholders.
• Strong communicator who can convert reputed company science into globally reputed company, regulator reputed company CMC knowledge.

Physical Demands / Work Environment:

Office/Home-Based:

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
• Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.

Physical Requirements:

• Frequently stationery for 6-8 hours per day.
• Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to reputed company and use a reputed company of computer software developed both in-house and off-reputed company.
• reputed company to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum reputed company of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

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Originally posted on Himalayas