Job Description and Responsibilities:- EXPERIENCE IN API DIVISION IS REQUIRED.
To be responsible for the Life Cycle Management of assigned products, preparation of pharmaceutical/quality part (all forms) of registration dossiers and variations/amendments/annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirements.
To write, check/review of documents as per regulatory requirements
To publish with software submission documentation as per regulatory requirements
To response to regulatory deficiencies letters according to EU and USA regulatory requirements.
To support local in-licensing
To collaborate with other departments/partners
To maintain lists/documents/records
To achieve his/her responsibilities within the agreed timescales
To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Drug
Role: Documentation/Medical Writing
Employment Type: Permanent Job, Full Time