Global Regulatory Informatics & Publishing Specialist

American Health Packaging; Hinoba-an; On-site; PHP 300,000 - 600,000; Full time

Job summary

PharmaLex India Private Limited. is seeking a Regulatory Informatics & Operations specialist to support dossier publishing and regulatory submissions for US and EU regions.

You will manage pre-publishing, compilation, and post-publishing activities and contribute to process improvements. The role requires a B.Pharm or science degree with 3+ years of experience, familiarity with US/EU eCTD submissions, and preferred Veeva publishing expertise.

Qualifications

• B.Pharm or other Science degree; M.Pharm preferred.
• Minimum 3 years of experience.
• Experience in regulatory informatics and operations.

Responsibilities

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Good understanding and participation in regulatory processes providing high-level Regulatory Informatics & Operations support in dossier Modules 1 to 5 for all applicable document types and Health Authority regions.
• Supporting pre-publishing, dossier compilation, dossier publishing and post-publishing activities.
• Good understanding and working knowledge of US and EU eCTD submissions across all submission types.
• Veeva Tool knowledge is preferred.
• To be able to work in CET/US shift timezone.

Skills

Submission publishing

US Publishing experience

Veeva tool experience

Veeva Publishing experience

Education

B.Pharm or other Science degree

M.Pharm preferred

Tools

Veeva

Job description

PharmaLex India Private Limited. is seeking a Regulatory Informatics & Operations specialist to support dossier publishing and regulatory submissions for US and EU regions.

You will manage pre-publishing, compilation, and post-publishing activities and contribute to process improvements. The role requires a B.Pharm or science degree with 3+ years of experience, familiarity with US/EU eCTD submissions, and preferred Veeva publishing expertise.