RA Executive

Role & responsibilities :

Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including amendments and product lifecycle management while ensuring compliance with relevant guidelines and regulations.

Documentation Management: Maintain, review, and update regulatory documentation, Analytical validations studies, Batch records, R&D documents before including  in the drug master files (DMFs). To check & confirm the compliance of documents as per the regulatory requirements.

Strong understanding of regulatory requirements, guidelines and standards, including ICH, FDA, EDQM, EMA and WHO regulations.

Cross-functional: Ability to interact effectively with R&D, quality assurance, and production, for proper and accurate documentation.

Communication:  Good English and excellent communication skills verbal and written  .