Regulatory Affairs Manager
Location
San Juan, San Juan | Argentina
Job description
Job Description – Regulatory Affairs Manager – New Drug Applications (NDA), Small Molecules
Reports To: Head, Strategic operations, and Regulatory Affairs
- Prepare and Review compilation of regulatory submissions like IND, NDA, responses to FDA queries, supplements, Meeting Packages and Proprietary Name requests with limited supervision.
- Provide regulatory guidance to cross functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms.
- Stay current and proactively implement new regulations published by the US FDA
- Establish and maintain effective internal and cross-functional team communications i.e. provide regular feedback and communicate work challenges/issues and successes.
- Identify technical gaps in the New and Filed applications and inform the Management/supervisor.
- Review and approve commercial labeling and complete drug listing for commercial products.
- Provide change control assessment and appropriate regulatory classification for post-approval changes proposed by the cross-functional teams.
- Maintenance of Electronic Submissions Gateway account and eCTD software
- Train and educate other associates as needed.
- Any other work assigned by the supervisor.
Requirements and Qualifications:
- Bachelor’s degree with 5 plus years’ experience in regulatory strategy and filing of New Drug Applications (NDA) in a pharmaceutical Industry.
- Hands on experience of using any e-CTD build software.
- Ability to multi-task in a fast-paced environment with minimal supervision.
- Ability to work flexibly, organize own workload and effectively manage competing priorities.
- Excellent attention to detail and accuracy maintaining consistently high-quality standards.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Willingness to learn new skills and flexibility to support business needs.
- Apply knowledge and expertise, to contribute to and provide solutions to process improvements.
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