Publishing Specialist
4 days ago
Key Responsibilities:
- Strong understanding of eCTD, NeeS, and ICH guidelines.
- Familiarity with Regulatory systems and Publishing tools.
- Use publishing tools such as: Lorenz Docubridge, Ectd Validator, ISI Toolbox, Adobe Acrobat, MS Excel, SharePoint.
- Ability to perform end-to-end eCTD submission process, including Document level Publishing and Dossier compilation, and dispatch of submissions to respective Health Authorities (Developed and ROW Markets)
- Manage lifecycle submissions including variations, amendments, and renewals.
- Perform document-level publishing, hyperlinking, bookmarking, and validation.
- Conduct quality control checks to ensure submission readiness.
- Collaborate with cross-functional teams including Regulatory Affairs, CMC, and Clinical.
- Stay updated with global regulatory guidelines (ICH, FDA, EMA).
Detail-oriented with a collaborative mindset.
Minimum Qualifications and Experience
- B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
Minimum 4 to 8 years
Preferred Qualifications/ Skills
- Proficiency in managing Regulatory eCTD Submission for all Global Markets.
- Good knowledge on eCTD Guidance and understanding validation criteria requirement.
- Strong communication and interpersonal skills.
- Experience with electronic submission (New Development Product Filings / LCM).
- Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
- High level of attention to detail and accuracy in document level publishing and submission compilation/validation.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using regulatory databases, information management systems, and other relevant software tools.
- Commitment to staying updated on regulatory changes and advancements in the field.
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