Assistant Manager/ Deputy Manager - Publishing

Azurity Pharmaceuticals

8 - 12 years

5 - 10 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

neurology interpersonal skills publishing compliance cardiovascular pharma product life cycle manager quality control information management endocrinology

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities

Oversee regulatory submissions activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.

Responsibilities:

Manage end-to-end publishing activities, including preparation, compilation, quality control, validation, and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements.
Supports submission planning and execution for initial marketing applications and post-approval lifecycle submissions (e.g., supplements, variations, renewals) across multiple regions including the US, Canada, EU, GCC, LATAM, MENA and APAC.
Performs thorough QC reviews to ensure submission-ready documents meet formatting, technical, and regulatory standards.
Interpret and apply key regulatory guidance, regional submission specifications, and evolving eCTD requirements (including ICH, FDA, EMA, GCC etc.)
Troubleshoots technical issues related to publishing tools and document formatting and resolving validation errors promptly.
Maintains compliant archival and storage of regulatory documents, ensuring alignment with regulatory and business needs.

Required Skills and Experience

Ability to read, understand, and follow FDA regulations and guidance documents related to publishing.
Proven experience collaborating within cross-functional teams to achieve shared objectives.
Strong attention to detail and ability to meet deadlines
Highly skilled at prioritizing and managing multiple tasks simultaneously.
Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person)
Strong sense of teamwork, ability to build collaborative relationships.
Adept at identifying, addressing, and escalating issues promptly to ensure resolution.
Familiar with Regulatory Information Management (RIM) systems like Veeva Vault and/or similar platforms.

Preferred Qualifications

8-12 years of pharmaceutical products publishing experience.
Bachelor s/ master s degree in scientific discipline preferred.

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