About us Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market. Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards. At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world. Together, we are shaping the future of healthcare and changing lives everywhere. About the role The Executive, Regulatory Affairs is responsible to support the company's regulatory compliance by preparing, compiling, submitting, and maintaining regulatory documentation for product registration dossiers, variation applications, and renewals in compliance with local regulatory requirements (e.g., NPRA, HSA, FDA, EMA, etc.). Senior roles will provide more strategic input and independently manage product portfolios or projects. Key Responsibilities:- 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 including R&D documents viz. IIG clearance, PDR, QoS, analytical methods validation protocols and reports; Review plant documents such as raw material, packaging material and finished product specifications and test procedures, batch records, process validation documents, all types of stability protocols and reports, and analytical method transfer/verification protocols and reports etc., 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 Compilation and review of labelling documents PIL, medication guide and review of art works in accordance with PLR labelling requirements 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 Compilation of SPL, ACTD, CTD and eCTD formats. Ensuring publishing activities and submission of dossiers via ESG with zero validation errors Regulatory Monitoring of an Approved Products About you Bachelor's degree in pharmacology or relevant. 3 years related experience in Pharma, FMCG, and Healthcare industries. Familiarity with ACTD/CTD/eCTD dossier formats and ASEAN/Common Technical Requirements (ACTR) as well as for overall global markers is an advantage Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of Generic products in ASEAN and other regulatory markets. Strong coordination with cross-functional teams to ensure timely documentation for original submissions, RTQs, and supplements, while effectively communicating, negotiating, and fostering diplomatic, collaborative working relationships. Strong intrapreneurial skills and mindset from start up to established organization. Versatile, meticulous and resilient, ability to multitask and stay positive in high-pressure ambiguous environments and work towards delivering results Proficient in Microsoft Office Suite Proficient in using software/tools relevant to the pharmaceutical or healthcare industry etc Show more Show less