Regulatory Affairs - Pharma
Job Description:
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Job Description
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-Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with cross functional team -Having experience for Drug listing and annual updates -Having ability to review documents as per current regulatory guidelines. - Have experience of compilation of Labelling section of US ANDA/EU MA -Preparation and review of artwork related to ANDA in line with innovator product -Maintain product life cycle for Labelling requirement inline with RLD updates -Submission of labelling SPL through software as per regulatory requirements -Have hand Ons experience for handling of E-CTD software |
Key Skills :
Company Profile
Company is rapidly growing ---ceutical company. engaged in the acquisition, licensing, development (ANDA), sales, marketing & distribution of generic ---ceuticals, drugs, and OTC (over the counter) non-prescription items for U.S. market.
In addition to their strategic partnerships, They have a highly experienced team of professionals who all work together to provide quality medicinal products. Their team specializes in analytical development & analysis, formulation development, regulatory affairs, quality control, quality assurance, manufacturing, accounting, marketing, distribution, and finance.
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