Regulatory Operations Principal Specialist

Fortrea; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Operations Principal Specialist in Mumbai. You will manage project management and regulatory affairs activities, ensuring compliance with health authorities' guidelines. The ideal candidate will have 7-9 years of experience in Regulatory Affairs or related fields, proficiency in English, and strong leadership capabilities. This is a full-time position, offering opportunities for growth and collaboration in a dynamic environment.

Qualifications

• 7-9 years of experience in Regulatory Affairs, Quality Assurance, or related fields.
• 1+ year of project and people management experience.
• Proficiency in English and other applicable languages.

Responsibilities

• Manage project management and regulatory affairs activities for clients.
• Coordinate and oversee Regulatory Operations across product lifecycle.
• Collaborate with Quality Assurance to develop SOPs and training material.

Skills

Analytical capabilities

Leadership capabilities

Strong organizational skills

Time-management skills

Client and regulatory compliance knowledge

Problem anticipation skills

Collaborative proficiencies

Education

Bachelor’s in pharmacy or related science

PhD or Master’s

Bachelor’s degree in Engineering/B.Tech

Tools

Microsoft Office

Document management systems

Job description

Regulatory Operations Principal Specialist

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Job Overview

Perform project management and regulatory affairs activities for Fortrea clients. Manage team performance, personnel issues, and assist Senior Management in resource allocation. Coordinate and oversee Regulatory Operations related to the creation, revision, compilation, and approval of specifications, regulatory and labeling documents across the product lifecycle for submission to U.S., EU, Japan, and other health authorities within agreed timelines. Provide high‑quality, cost‑effective service to both internal and external clients.

Summary Of Responsibilities

• Provide analytical support for developmental and comparative dissolution projects received from other Janssen sites.
• Serve as interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations.
• Coordinate with CRO to ensure project completion within timelines.
• Design scientific experiments, monitor lab work, and recommend changes based on experimental results.
• Prepare test methods, technical documents, protocols, and reports as required.
• Ensure proper recording of information; retain records and raw data; summarize, interpret, review data, and draw conclusions.
• Analyze and interpret dissolution data sets.
• Troubleshoot instrument or method problems.
• Follow GMP and safety requirements related to assigned activities.
• Participate in process improvement initiatives.
• Work closely with clients to ensure satisfaction and meet or exceed Service Level Agreements.
• Collaborate with the Quality Assurance department to develop SOPs and training material.
• Assist in training and mentoring of the project team.
• Implement process and productivity improvements to enhance operational efficiency.
• Participate in client or regulatory agency audits.
• Contribute to solving technical and operational problems identified by project members.
• Collaborate with company leadership to define project objectives, processes, policies, and procedures.
• Maintain knowledge of product information.
• Participate in cross‑functional meetings as needed.
• Share relevant information from internal and external meetings with appropriate colleagues.
• Help generate, review, and implement SOPs, Work Instructions, etc.
• Ensure records and raw data are properly retained.

Qualifications (Minimum Required)

• Bachelor’s in pharmacy or related science (or equivalent); advanced degree (PhD or Master’s) with 7‑9 years of experience. Fortrea may consider relevant equivalent experience.
• Bachelor’s degree in Engineering /B.Tech /Packaging /Polymer Հայաստան /Printingревиз; 79 years of packaging experience or 7‑9 years of advanced packaging experience preferred. Equivalent experience may be considered.
• Proficiency in English and other applicable languages.

Experience (Minimum Required)

• Multimedia dissolution testing.
• Knowledge of FDA‑SUPAC, ICH, and emerging market guidelines for dissolution studies.
• 1+ year of project and people management experience.
• 7‑9 years of industry experience in Regulatory Affairs, Quality Assurance, Analytical science, Packaging, Polymer or Printing, Formulation science, or related drug development.
• Technical proficiency with Microsoft Office, document management, and publishing tools.
• Understanding of the pharmaceuticalİR product life cycle and regulatory requirements, GxP, and ICH‑GCP.
• Strong organizational and time‑management skills.
• Analytical capabilities and customer focus.
• Excellent verbal, written, and presentation skills.
• Leadership capabilities.
• High accuracy and attention to detail.
• Client and global regulatory compliance knowledge.
• Problem anticipation and corrective action skills.
• Aptitude for audit situations.
• Team‑player attitude.
• Decision‑making skills.
• Collaborative proficiencies.
• Planning and execution capabilities.
• Knowledge of in‑vitro dissolution testing.
• Comparative dissolution testing, including multimedia dissolution.
• phant interface with contract labs.
• Dissolution investigations.
• Basic knowledge of oral solid dosage formulation.

Preferred Qualifications Include

• Same educational and experience preferences as in Minimum Required.
• Knowledge of data management systems, product life cycle, and MIS.
• 1+ year of project and people management experience.
• Diploma or certification in Regulatory Affairs.

Physical Demands/Work Environment

• Travel 5‑10% of the time, including overnight stays, as needed.
• Work environment: Office or remote.

Location: Mumbai, Maharashtra, India

Seniority level: Mid‑Senior level

Employment type: Full‑time

Job functionulala: Legal

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