Pharmaceutical Regulatory Affairs Consultant

Job Title: Pharmaceutical Regulatory Affairs Consultant

Company

Pharmnova Medical Research

Engagement Type

Consultant / Freelance / Part-Time / Project-Based

Location

Remote / Work from Home

Experience

8-15+ Years

Industry

Pharmaceutical / Biotechnology / Life Sciences

Job Overview

Pharmnova Medical Research is seeking an experienced Pharmaceutical Regulatory Affairs Consultant to provide professional consultancy and subject-matter expertise in pharmaceutical regulatory affairs and regulatory operations.

The consultant will be responsible for sharing practical knowledge, regulatory requirements, operational processes, documentation standards, and industry practices associated with pharmaceutical regulatory activities across different countries and regulatory jurisdictions.

We are looking for a professional with hands-on experience in managing pharmaceutical regulatory activities, including product registration, marketing authorization, regulatory submissions, renewals, variations, regulatory lifecycle management, and interactions with health authorities.

The ideal candidate should have practical experience working in a pharmaceutical company's Regulatory Affairs department, a CRO, or a regulatory consulting organization.

Key Responsibilities1. Product Registration and Marketing Authorization

• Explain end-to-end pharmaceutical product registration processes across different countries and regulatory jurisdictions.
• Identify registration requirements for new pharmaceutical products, generic drugs, biological products, and other relevant product categories.
• Define country-specific registration pathways, application procedures, timelines, and regulatory requirements.
• Explain requirements for obtaining Marketing Authorization (MA) and maintaining product registrations.
• Identify required documents, forms, certificates, declarations, and supporting evidence for registration applications.
• Explain requirements for new product applications, line extensions, and additional strengths or dosage forms.

Regulatory Dossier Preparation and Submission

• Explain regulatory dossier requirements and submission procedures, including CTD and eCTD formats.
• Identify the documents and information required under CTD modules 1–5.
• Explain Module 1 country-specific administrative and regulatory requirements.
• Identify requirements for Quality, Non-clinical, and Clinical documentation.
• Explain dossier compilation, technical validation, publishing, and submission processes.
• Identify regulatory submission checklists, document specifications, templates, and quality review requirements.
• Explain procedures for responding to regulatory authority queries and deficiency letters.

Regulatory Lifecycle Management

• Explain processes and requirements for
• Marketing Authorization renewals.
• Product variations and post-approval changes.
• Manufacturing site changes.
• Changes in formulation, composition, and specifications.
• Changes in product labelling, packaging, and artwork.
• Changes in manufacturing processes and analytical methods.
• Change of Marketing Authorization Holder (MAH).
• Product discontinuation, suspension, and withdrawal.
• Identify variation classifications, approval requirements, submission timelines, and implementation conditions.
• Explain procedures for maintaining and updating product registration records.

Regulatory Intelligence and Country-Specific Requirements

• Identify applicable regulatory authorities and their roles in different countries.
• Explain regulatory frameworks and guidelines applicable to pharmaceutical products.
• Identify country-specific regulatory requirements, application forms, fees, documentation, and submission procedures.
• Explain how regulatory changes, new guidelines, and updated requirements are monitored and implemented.
• Identify reliable regulatory information sources and official health authority portals.
• Provide comparative insights into regulatory requirements across major pharmaceutical markets.

Regulatory Documentation and Compliance

• Explain preparation, review, approval, and maintenance of regulatory documents.
• Identify requirements for certificates such as CPP, GMP certificates, Free Sale Certificates, and other supporting regulatory documents, as applicable.
• Explain product labelling, packaging, prescribing information, SmPC, PIL, and package insert requirements.
• Identify document control, version management, archival, and regulatory record-retention requirements.
• Explain regulatory compliance activities, inspection readiness, and regulatory audit requirements.

Regulatory Authority Interactions

• Explain procedures for regulatory authority communications and correspondence.
• Identify processes for responding to deficiency letters, clarification requests, and technical queries.
• Explain requirements for pre-submission meetings, regulatory consultations, and post-submission follow-ups.
• Define processes for tracking application status, regulatory commitments, approval conditions, and submission deadlines.

Other Regulatory Affairs Activities

• Explain regulatory requirements related to
• Clinical trial applications and regulatory approvals.
• Import and export permits and licences.
• Investigational medicinal products.
• GMP and manufacturing-related regulatory approvals.
• Pharmacovigilance-related regulatory submissions and safety reporting, where applicable.
• Regulatory requirements for variations arising from safety or quality changes.
• Identify coordination and information exchange requirements between Regulatory Affairs, Quality Assurance, Manufacturing, Clinical Operations, Pharmacovigilance, and other departments.

Consultancy Deliverables

• Provide structured documentation of regulatory processes and operational workflows.
• Prepare regulatory activity-wise checklists and documentation requirement matrices.