Executive Regulatory Affairs

Exemed

5 - 7 years

6 - 8 Lacs

vadodara

Posted:4 hours ago| Platform:

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Skills Required

drug regulatory affairs regulatory affairs dossier preparation api ra ctd dossier compilation dmf

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.
Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.
To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.
Responsible for prepare and review Drug Master File as per respective reulatory agency guidline.
Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies.
To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline.
Responsible for prepare Drug Master File (DMF) Deficiency response to respective regulatory agency.
Responsible for prepare Drug Master File (DMF) Amendment report to respective regulatory agency.
Responsible for prepare Drug Master File (DMF) Annual update report to respective regulatory agency.
Assessment and notification of change to regulatory agency and customer as per regulatory requirement.
Aim to serve as an internal API regulatory expert, ensuring regulatory compliance within the cross-functional teams.
Responsible for scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements including continuous improvement programs.

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