Technology Research Associate at Smartedge Solutions
Job Description:
Responsibilities:
* Responsible for executing the content management of core data sheet (CDS) and local product documents (LPDs)
* Responsible for updating as per the local safety signals
* Keep up to date with regional labeling regulations
* Authoring labelling submission package
* Coordinate and preparation of translation in Local language
* Creation of gap analysis of the local labels and providing references of supportive literature and publications for the updated text
* Proofread documents prepared by team
Qualifications:
* Masters in Lifesciences or equivalent with 5-8 years of experience in regulatory Affairs/Labelling or equivalent
* Knowledge of the principles and concepts of Labelling, including generics, authorized generics, private labels, device/combination products, how to read and interpret HA regulations and guidance, and underlying SOPs
* Ability to identify discrepancies/issues in local implementation of corporate labels and contact the affiliates (if appropriate) for remediation actions
* Must be able to construct a Company Response (MAH response) for health authority questions
* Preferred qualifications: Excellent communication and PC skills
Please share your updated resume in this email id pratyusha.g@smartedgesolutions.co.uk, so that I can reach you earlier.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Legal
Industries
IT Services and IT Consulting
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