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Regulatory and Quality Applications at ASPEN PHARMA PTY LTD

Dubai, Dubai, United Arab Emirates -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 26

Salary

50000.0

Posted On

22 Sep, 26

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Pharmaceutical Manufacturing

Description

regulatory medical writing experience at a pharmaceutical sponsor, CRO, or as an independent consultant.
Direct experience independently authoring or leading full Clinical Study Reports, beyond summaries or partial contributions.
Strong knowledge of ICH E3 and conventions for periodic safety documentation, including ICH E2F and ICH E2C.
Understanding of eCTD placement and clinical regulatory documentation conventions.

Responsibilities

regulatory medical writing experience at a pharmaceutical sponsor, CRO, or as an independent consultant.
Direct experience independently authoring or leading full Clinical Study Reports, beyond summaries or partial contributions.
Strong knowledge of ICH E3 and conventions for periodic safety documentation, including ICH E2F and ICH E2C.
Understanding of eCTD placement and clinical regulatory documentation conventions.