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Regulatory Operations Specialist Ii | Pharmaceutical Analytical & Regulatory Operations

Fortrea
Fortrea
4-7 years
preferred by company
Mumbai, India
1 May 12, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Regulatory Operations Specialist II | Pharmaceutical Analytical & Regulatory Operations

Job Location: Mumbai, India
Job Type: Full-Time
Department: Clinical / Regulatory Operations / Pharmaceutical Sciences
Work Mode: Office-Based / Remote / Hybrid (As per business requirements)
Travel Requirement: As per business needs
Experience Required: 4–7 Years
Freshers Eligible: No
Industry: Pharmaceuticals / Clinical Research / Regulatory Affairs / Analytical Sciences / Drug Development

Job Overview

We are hiring a Regulatory Operations Specialist II for a pharmaceutical analytical and regulatory operations role in Mumbai. This opportunity is ideal for experienced professionals with expertise in comparative dissolution studies, pharmaceutical analytical testing, regulatory compliance, formulation science, quality assurance, and drug development operations.

The selected candidate will support pharmaceutical development projects, analytical investigations, regulatory documentation, quality compliance activities, and scientific project coordination across global healthcare programs.

This role is highly suitable for professionals seeking career growth in regulatory operations, pharmaceutical analytics, drug development, formulation support, and quality-driven healthcare operations.

Key Responsibilities

  • Provide analytical support for developmental pharmaceutical projects and comparative dissolution studies.
  • Coordinate with CROs, contract laboratories, suppliers, internal teams, and clients to ensure project delivery within timelines.
  • Design scientific experiments and actively oversee analytical laboratory work.
  • Develop and prepare:
    • Test methods
    • Scientific protocols
    • Analytical reports
    • Technical documentation
    • SOPs
    • Work instructions
  • Maintain accurate documentation, raw data records, and scientific audit trails.
  • Analyze and interpret dissolution study datasets to support pharmaceutical decision-making.
  • Troubleshoot issues related to laboratory instruments, analytical methods, and testing workflows.
  • Perform work in compliance with GMP, safety requirements, and pharmaceutical quality standards.
  • Conduct multimedia dissolution testing and comparative in-vitro dissolution studies.
  • Apply regulatory knowledge related to:
    • FDA SUPAC guidelines
    • ICH compliance requirements
    • Emerging market pharmaceutical regulatory expectations (e.g., China, Latin America)
  • Support formulation-related analytical activities for oral solid dosage forms.
  • Participate in continuous process improvement and productivity enhancement initiatives.
  • Collaborate with quality assurance teams to develop SOPs, training materials, and operational best practices.
  • Mentor project team members and support knowledge-sharing initiatives.
  • Participate in client audits, regulatory inspections, and internal compliance reviews.
  • Support SLA-driven client delivery, scientific reporting, and stakeholder communication.
  • Contribute to project governance, cross-functional meetings, and operational problem-solving.

Required Qualifications

Candidates should meet one of the following educational criteria:

Option 1:

  • Bachelor’s degree in:
    • Pharmacy
    • Pharmaceutical Sciences
    • Life Sciences
    • Related scientific disciplines

Option 2:

  • Advanced qualifications such as:
    • Master’s Degree
    • PhD
    • Equivalent scientific academic credentials

Option 3:

  • Technical or engineering qualifications in:
    • B.Tech
    • Packaging Engineering
    • Polymer Science
    • Printing Technology
    • Packaging Postgraduate Certification / Diploma

Equivalent relevant experience may be considered.

Experience Requirements

  • Minimum 4–7 years of experience in pharmaceutical analytical sciences, regulatory affairs, quality assurance, formulation science, packaging compliance, or drug development
  • Strong experience in regulated pharmaceutical or life sciences environments required
  • Exposure to dissolution studies, analytical testing, or regulatory support highly preferred
  • Freshers are not eligible