career opportunities in Regulatory Affairs at Acme Generics, Ahmedabad. This article provides details about vacancies for Executive, Assistant Manager, and Deputy Manager roles in the Regulatory Affairs department. Learn more about qualifications, responsibilities, and how to apply.
Job Title: Executive/Assistant Manager/Deputy Manager
Department: Regulatory Affairs - Injectable (US/Europe)
Experience: 5 to 12 Years
Qualification: M.Pharma
Location: Ahmedabad
Role and Responsibilities The position holder will be responsible for: Compilation of ANDAs and 505(b)(2) applications (pIND meetings, IND submissions, Brand Name submissions) with USFDA·
- Experience in submission of pre-ANDA meetings for complex products with USFDA
- Review of DMFs of complex peptide drug substances
- Ensure timely response submission for ANDA deficiencies i.e., IR, CRL and DRL
- Ensure Labeling compilation, including SPL and side by side comparison against RLD labels with highlighted annotation of changes
- QBR compilation for drug substance and drug product; Sterility assurance QBR
- Experienced with handling drug device combination regulations and understand the requirements for submission of Threshold Analysis report and Human Factor Engineering studies protocols and reports. Review and approve of Design History File
- Controlled correspondence submission with the regulatory authorities for bioequivalence recommendations & inactive ingredient levels and Q1 and Q2 sameness evaluation which are essential during the product development stage before the submission of an application
- Supplements filling for addition of alternate facility and CMC related changes, e.g., PAS, CBE-30 and CBE-0
- Life cycle management of products & approving the change controls and ensure product continuity through filing and timely approvals of supplements. Support the continuity activities through co-ordination with various stakeholders
- Approval package compilation and provide support for lunching of the approved ANDA product
- Ensure product compliance with respect to approvals and regulatory requirements
- Tracker management-Maintenance of ANDA filing status, deficiency, approval, labelling and new launch status
