Regulatory Operations Principal Specialist

Fortrea

1-9 years

preferred by company

India Mumbai

10 Jan. 14, 2026

Job Description

Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Operations Principal Specialist

Location: Mumbai, India
Employment Type: Full-Time
Work Model: Office-based / Hybrid (as per business needs)
Application Deadline: January 20, 2026
Job Requisition ID: 255942

Job Overview

We are seeking an experienced Regulatory Operations Principal Specialist to lead and manage regulatory operations, quality-driven documentation, and project management activities for global pharmaceutical clients. This role plays a critical leadership position in overseeing regulatory submissions, labeling documentation, compliance investigations, and quality system operations across the product lifecycle.

The successful candidate will manage cross-functional teams, support senior management in resource planning, and ensure timely, compliant submissions to global health authorities including US FDA, EMA, PMDA (Japan), and Rest of World (ROW) agencies. The role requires a strong blend of regulatory expertise, quality assurance acumen, scientific judgment, and people leadership.

Key Responsibilities

Regulatory Operations & Quality Leadership

Manage, coordinate, and oversee end-to-end regulatory operations activities, including creation, revision, compilation, review, and approval of regulatory and labeling documents across the product lifecycle.
Review and approve documents, investigations, and compliance actions using electronic quality and regulatory platforms (e.g., COMET, TruVault or equivalent).
Lead investigations related to Non-Conformances, OOS, OOE, and OOT, ensuring scientifically sound and compliant documentation.
Author and review scientific and regulatory-compliant investigation reports in alignment with global quality standards.

Project & Team Management

Manage and mentor team members, including performance reviews, coaching, and development planning.
Support senior leadership with resource allocation, project planning, and workload management.
Identify risks, troubleshoot operational issues, resolve conflicts, and implement effective solutions.
Ensure delivery of services meets or exceeds client expectations and defined SLAs.

Quality Systems, Audits & Continuous Improvement

Prepare and maintain weekly quality dashboards and quality improvement plans, including metrics, statistics, trend analysis, and presentations.
Support internal audits, external audits, and inspection readiness activities.
Coordinate and facilitate training programs through learning management systems (e.g., Summit platform).
Implement and support daily laboratory and quality system processes, including training management and reference standard management.
Perform gap assessments and lead preparation and revision of SOPs and controlled documents within electronic document management systems.
Drive process improvement initiatives aligned with evolving QA and business needs.

Qualifications

Education (Minimum Requirement)

One of the following:

Bachelor’s degree in Pharmacy or related scientific discipline with 7–9 years of relevant experience
Master’s or PhD in Pharmaceutical, Chemical, or Biological Sciences with 7–9 years of industry experience
Bachelor’s degree in Engineering (B.Tech – Packaging, Polymer, Printing) with 7–9 years of relevant packaging industry experience
Equivalent combination of education and experience may be considered

Experience Required

Minimum 7–9 years of relevant experience in the pharmaceutical industry
Experience across one or more areas:
- Regulatory Affairs
- Regulatory Operations
- Quality Assurance
- Analytical Sciences
- Packaging / Polymer / Printing
- Formulation Science or Drug Development
At least 1 year of experience in project management and people management is preferred
Strong knowledge of:
- Global regulatory requirements and submission processes
- GxP standards and ICH-GCP guidelines
- Pharmaceutical product lifecycle and manufacturing processes

Key Skills & Competencies

Strong leadership, decision-making, and stakeholder management skills
Excellent analytical, organizational, and time management abilities
High attention to detail with a strong quality and compliance mindset
Ability to manage audits and regulatory inspections confidently
Proficiency in Microsoft Office, document management, and publishing tools
Excellent verbal, written, and presentation skills
Ability to work independently and effectively in a global, matrixed environment
Proactive, adaptable, and continuous-improvement oriented

Preferred Qualifications

Diploma or certification in Regulatory Affairs
Knowledge of data management systems, MIS, and electronic quality platforms
Prior experience supporting global regulatory submissions and inspections
Exposure to global client-facing regulatory operations roles

Work Environment & Travel

Office-based or hybrid work environment
Willingness to travel 5–10% regionally or globally, including overnight stays as required

Why This Role

This is a senior leadership opportunity to drive global regulatory operations excellence, influence quality strategy, and lead high-impact regulatory and compliance initiatives for multinational pharmaceutical clients.

Apply now on thepharmadaily.com to advance your career as a Regulatory Operations Principal Specialist in the global pharmaceutical and CRO industry.

Job Title: Regulatory Operations Principal Specialist

Location: Mumbai, India
Employment Type: Full-Time
Work Model: Office-based / Hybrid (as per business needs)
Application Deadline: January 20, 2026
Job Requisition ID: 255942

Job Overview

Key Responsibilities

Regulatory Operations & Quality Leadership

Manage, coordinate, and oversee end-to-end regulatory operations activities, including creation, revision, compilation, review, and approval of regulatory and labeling documents across the product lifecycle.
Review and approve documents, investigations, and compliance actions using electronic quality and regulatory platforms (e.g., COMET, TruVault or equivalent).
Lead investigations related to Non-Conformances, OOS, OOE, and OOT, ensuring scientifically sound and compliant documentation.
Author and review scientific and regulatory-compliant investigation reports in alignment with global quality standards.

Project & Team Management

Manage and mentor team members, including performance reviews, coaching, and development planning.
Support senior leadership with resource allocation, project planning, and workload management.
Identify risks, troubleshoot operational issues, resolve conflicts, and implement effective solutions.
Ensure delivery of services meets or exceeds client expectations and defined SLAs.

Quality Systems, Audits & Continuous Improvement

Prepare and maintain weekly quality dashboards and quality improvement plans, including metrics, statistics, trend analysis, and presentations.
Support internal audits, external audits, and inspection readiness activities.
Coordinate and facilitate training programs through learning management systems (e.g., Summit platform).
Implement and support daily laboratory and quality system processes, including training management and reference standard management.
Perform gap assessments and lead preparation and revision of SOPs and controlled documents within electronic document management systems.
Drive process improvement initiatives aligned with evolving QA and business needs.

Qualifications

Education (Minimum Requirement)

One of the following:

Bachelor’s degree in Pharmacy or related scientific discipline with 7–9 years of relevant experience
Master’s or PhD in Pharmaceutical, Chemical, or Biological Sciences with 7–9 years of industry experience
Bachelor’s degree in Engineering (B.Tech – Packaging, Polymer, Printing) with 7–9 years of relevant packaging industry experience
Equivalent combination of education and experience may be considered

Experience Required

Minimum 7–9 years of relevant experience in the pharmaceutical industry
Experience across one or more areas:
- Regulatory Affairs
- Regulatory Operations
- Quality Assurance
- Analytical Sciences
- Packaging / Polymer / Printing
- Formulation Science or Drug Development
At least 1 year of experience in project management and people management is preferred
Strong knowledge of:
- Global regulatory requirements and submission processes
- GxP standards and ICH-GCP guidelines
- Pharmaceutical product lifecycle and manufacturing processes

Key Skills & Competencies

Strong leadership, decision-making, and stakeholder management skills
Excellent analytical, organizational, and time management abilities
High attention to detail with a strong quality and compliance mindset
Ability to manage audits and regulatory inspections confidently
Proficiency in Microsoft Office, document management, and publishing tools
Excellent verbal, written, and presentation skills
Ability to work independently and effectively in a global, matrixed environment
Proactive, adaptable, and continuous-improvement oriented

Preferred Qualifications

Diploma or certification in Regulatory Affairs
Knowledge of data management systems, MIS, and electronic quality platforms
Prior experience supporting global regulatory submissions and inspections
Exposure to global client-facing regulatory operations roles

Work Environment & Travel

Office-based or hybrid work environment
Willingness to travel 5–10% regionally or globally, including overnight stays as required

Why This Role

Apply now on thepharmadaily.com to advance your career as a Regulatory Operations Principal Specialist in the global pharmaceutical and CRO industry.a

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Regulatory Operations Principal Specialist

Job Description

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