Job Description :

- Accountable to support all activities related to CTA submissions in IM

- Create a database of clinical requirements for CTA submission in IM

- Work closely with global R&D members and provide CTA filing strategy and guidance on local regulatory requirements

- Review and approve CTA submissions in IM

- Coordinate responses to Health Authorities, following CTAs submission, with appropriate personnel and departments to resolve outstanding regulatory issues.

- Liaise with the clinical trial CRO as IMRA representative, as needed

- Accountable to lead all activities related to DMFs submission in CN (of API, excipients and packaging materials)

- Work closely with site QA, SC, procurement and local CN RA to achieve timely submission and approval of required DMFs

- Ensure that cross-functional activities to support submissions of DMFs in CN are in compliance with regulatory requirements. 

- Identify gaps and propose/support solutions to address them that are consistent with regulatory requirements. 

- Initiation and/or participation in teleconferences and/or meetings related to the topic/project under lead (to clarify issues, solve issues, discuss changes and strategy, check timelines and availability of documents, etc.).

Labeling activities :

- Other duties as assigned or as business needs require.

- Required: BSc/MSc in chemistry/biology/biotechnology/pharmacy or similar scientific field

- At least 5 years of experience in regulatory affairs for pharmaceuticals/biologics (or equivalent combination of regulatory and related work experience)

- Previous experience in clinical operations/CRO company

- Familiarity with CTD format and ICH requirements for registration of pharmaceuticals/biologics/devices

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