Executive - Regulatory and Scientific Affairs

Novumgen

2 - 4 years

3 - 5 Lacs

ahmedabad

Posted:2 days ago| Platform:

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Skills Required

ich guidelines europe uk documentation regulatory submissions maa

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role Overview:

Preparation, review, and submission of responses to deficiency letters raised by the UK/EU regulatory agencies during the evaluation of Marketing Authorisation Applications (MAAs). The role ensures high-quality and compliant responses in line with regulatory expectations and timelines.

Key Responsibilities:

Coordinate with cross-functional teams (Development, Clinical, Nonclinical, Pharmacovigilance, Quality, Manufacturing, etc.) to obtain required information and justifications.
Consolidate and review all data and documents to ensure consistency, accuracy, and regulatory compliance prior to submission.
Draft and review responses addressing concerns on quality, safety, and efficacy aspects.
Ensure alignment with regulatory guidelines (MHRA guidance, EU guidance, ICH guidelines, etc.).
Maintain consistency across the dossier.
Ensure all responses meet formatting and procedural requirements (e.g., eCTD structure, proper referencing, etc.).
Adhere to internal quality systems, SOPs, and regulatory documentation control procedures.

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