Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Role and Responsibilities

Role: Preparation, compilation, publishing and delivery of electronic regulatory submissions (eCTD) in compliance with global Health Authority requirements and internal standards.

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.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.

Assistant Manager/ Deputy Manager - Publishing

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