Regulatory Affairs Expert for Global Markets
10 hours ago
As a Regulatory Affairs Expert for Global Markets at Panacea Biotec, you will be responsible for ensuring the successful filing of dossiers in regulated markets without any major queries or deficiencies. You will respond to regulatory body queries within stipulated timelines and minimize queries. Proper maintenance of records and their archival is also crucial.
Key Responsibilities:
1. Compile registration dossiers in developed markets (ANDA, NDA & MAA) with accuracy and efficiency.
2. Leverage experience in regulatory aspects of Advanced Drug Delivery Systems, including nanoparticles/liposomal and microparticulate systems, to drive growth.
3. Proactively address regulatory aspects of drug-device combinations to ensure compliance.
4. Familiarize yourself with eCTD filing using docubridge software to streamline processes.
5. Finalize structured product labeling (SPL) using LabelBridge software for effective market presence.
6. Review various documents received from vendors, R&D, QA, QC, CRD & Regulatory authorities, such as DMF's specifications, stability data, validation data, COA's, MFC & CMC, to ensure quality standards are met.
7. Respond promptly to queries / deficiencies from Different Regulatory Authorities.
8. Prepare and file IND and first-to-file Para IV type of applications efficiently.
9. Maintain accurate records and their archival to facilitate seamless tracking and analysis.
10. Respond effectively to queries from different regulatory authorities within stipulated timelines.
Skill Set Required:
1. Proven experience in filing regulated markets for innovative and generic formulations.
2. Involvement in Tech Transfer, Development, and regulatory requirements to drive success.
3. Strong understanding of requirements for CMC to ensure compliance.
4. e-CTD Submission expertise to streamline processes.
5. Regulatory exposure from filings to launch to guarantee a smooth transition.
6. Due-Diligence of dossiers for in-licensing of products to identify potential opportunities.
7. Effectively guide stakeholders (R&D, Manufacturing, BD, and Marketing) on regulatory feedback to foster collaboration.
8. Evaluate regulatory consultants for the said market to inform strategic decisions.
9. Prepare budgets to manage resources effectively.
Salary: $120,000 - $180,000 per annum, based on qualifications and experience.
About Us:
Panacea Biotec is a leading pharmaceutical company committed to delivering innovative solutions for better healthcare outcomes.
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