Sr Associate - Assistant Manager

Ddreg Pharma; Gurugram District; Vor Ort; INR 1.200.000 - 2.100.000; Vollzeit

Zusammenfassung

DDReg Pharma Pvt. Ltd. in Gurgaon, India, seeks a Senior Associate/Assistant Manager, Regulatory Affairs (Emerging Markets) to manage regulatory submissions, approvals, and lifecycle activities across Asia-Pacific, ASEAN, LATAM, CIS, Middle East, Africa and other global markets.

You will prepare dossiers in CTD/eCTD formats, coordinate with CMC, QA, Manufacturing and Pharmacovigilance, liaise with agencies and ensure timely registrations, variations, and labeling changes.

Qualifikationen

• Experience in dossier preparation, product registrations, and regulatory compliance.

Aufgaben

• Develop regulatory strategies for product registrations, renewals, variations, and line extensions across Emerging Markets.
• Ensure compliance with country-specific regulatory requirements and pharmaceutical regulations.
• Coordinate with internal teams to obtain regulatory documentation and ensure submission readiness.
• Act as liaison with local regulatory authorities and approvals teams to ensure timely closures of commitments.

Kenntnisse

Regulatory strategy

Regulatory submissions

Cross-functional coordination

Regulatory compliance

Jobbeschreibung

Department: Regulatory Affairs Location: Gurgaon Reports To: Head Regulatory Affairs / Director Regulatory Affairs

Job Purpose

The Senior Associate Assistant Manager / Regulatory Affairs (Emerging Markets) will be responsible for managing regulatory submissions, approvals, and lifecycle management activities across Emerging Markets, including Asia-Pacific, ASEAN, LATAM, CIS, Middle East, Africa, and other global markets. The role requires expertise in dossier preparation, product registrations, regulatory compliance, regulatory agency liaison, and cross-functional coordination to ensure timely approvals and uninterrupted business operations.

Key Responsibilities

Regulatory Strategy Compliance

• Develop and execute regulatory strategies for product registrations, renewals, variations, and line extensions across Emerging Markets.
• Ensure compliance with country-specific regulatory requirements, guidelines, and pharmaceutical regulations.
• Assess regulatory risks and recommend mitigation plans for successful registrations and product launches.
• Monitor regulatory changes and communicate their impact to internal stakeholders.

Product Registration Lifecycle Management

• Prepare, review, compile, and submit registration dossiers in CTD/eCTD and country-specific formats.
• Manage lifecycle activities including:
• Variations/Amendments
• Renewals
• Site Transfers
• MAH Transfers
• Labeling Changes
• Product Withdrawals
• Coordinate timely approvals to support commercial and supply chain objectives.
• Maintain registration status and approval trackers for assigned markets.

Dossier Preparation Submission Management

• Coordinate with CMC, Quality Assurance, Manufacturing, Clinical, Pharmacovigilance, and Supply Chain teams to obtain regulatory documentation.
• Review Module 1 and country-specific submission requirements.
• Ensure completeness and quality of dossiers before submission.
• Support electronic submissions wherever applicable.

Regulatory Agency Interaction

• Act as the primary contact for local regulatory authorities, distributors, and regulatory consultants.
• Coordinate responses to agency queries, deficiency letters, and information requests.
• Ensure timely closure of regulatory commitments and approvals.
• Support inspections, audits, and regulatory meetings when required.

Labeling Artwork Management

• Review and approve product labeling, package inserts, artworks, and promotional materials as per local market requirements.
• Coordinate implementation of approved labeling changes with internal and external stakeholders.
• Ensure compliance with local language and country-specific labeling regulations.

Job Category

Regulatory Affairs