CMC

Job role - CMC Regulatory Affairs

Experience - 3-8 Years

Location - Bengaluru

Mode - Hybrid

Manage submissions

Plan submission workload by reviewing/monitoring RIM for planned documents for

registration submissions.

Partner with the Global Regulatory Associate and Regional Submission Associate to

retrieve, publish, and submit

Modules 1-5 reports/documents and combine files into electronic submissions (eCTD)

and/or non-eCTD submissions according to the master table of contents or Content

Plan for the dossier.

Coordinate global registration activities and provide the necessary documentation to

affiliates for registration of products in global countries

Submit and archive submissions

Submit and archive submitted submissions, assuring all metadata fields are complete

in RIM.

Manage FDA Web trader account to enable submissions via electronic gateway.

Assure all appropriate metadata fields are completed when archiving in electronic

filing system (RIM).

Assure accurate entry for future retrieval of submissions if/when requested

Build on high level of expertise in electronic publishing

Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe

Acrobat, Submission Validation software (Lorenz), ISIToolbox.

Successfully complete the formal training modules.

Stay up to date on system and tool upgrades that impact publishing.

Share technical information among staff members and apply what is learned in dayto-

day work.

Apply learning from quality review of submission work.

Keep up to date in subject matter expert area.

Build technical and quality expertise

Understand changes to Regulatory Guidance and Requirements and advise RDE

Management as to their potential impact on Publishing.

Keep current on latest quality improvement methods.

Ensure best practices through partnership with Regulatory Quality