Overall Novuge n is a wholly owned subsidiary company of a UAE based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast and successful experience of venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. Novugen's passion for science and bold global strategy prepared us to respond to challenges of bringing hard-to-source and technology-intensive pharmaceutical products to the market Novugen specializes in niche and difficult to formulate generics for all therapeutic areas of pharmaceutical and oncology drug products while meeting stringent global quality standards. With vertical integration from Active Pharmaceutical Ingredients (API) to Finished Products R&D and manufacturing based in Malaysia, it gives us greater control over the supply chain. Our pharmaceutical and oncology manufacturing facilities in Bandar Enstek, Negeri Sembilan are the first in Malaysia and the only in Southeast Asia with approval from USFD The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We are committed to ensuring early access to high-quality products that lack robust generic alternatives due to their complexity. Our vision is to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2025, competing in global marke Job Descriptions: Authoring and submission of (all modules - M1 to M5) of Original ANDAs, response to queries, and life cycle management of dossier such as annual reports, CBE, CBE-30 and PAS. Ensure no major queries during review cycle of to secure the first review cycle approval and ensure the GDUFA goal dates are met. Ensure GDUFA requirements such as Drug listing, Fee, Self-identification of facilities etc. Identify, review, and approve the required documents received towards dossier compilation. Writing Controlled correspondences (standard and complex) correspondences. Thorough understanding on USP and EP requirements while reviewing the specification and keep updating the team with the current requirements. Review and compilation of relevant section of clinical, bio analytical reports, and bio-summary tables received towards the regulatory submissions. Review/Approve the change controls and deviations related to RA decision tree. To liaise with various contract organizations, and other outside stake holders on current Agency's regulatory requirements and align them with product goals. Ensuring regulatory compliances of DMFs in connection with marketing applications. Review of SPL and eCTD with zero validation errors. Regulatory Monitoring of an Approved Products. Job Requirements: Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of Generic products in US. Proactive, quick learner and independent worker able to effectively multi-task in a high-pressure environment and follow issues through to conclusion. Team-player, able to positively influence team members at all levels with an entrepreneurial 'can do' attitude. Experience in handling all cross functional teams to ensure timely documentation for submission of original submissions, RtQs, and supplements.