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 incumbent will lead the US Regulatory team and collaborate with cross-functional departments, including the senior management team, in developing and executing Regulatory Affairs strategies to achieve the company's objectives.
Key Responsibilities:
- Timely submission of variations/amendments of registered product details as required by regulatory authorities.
- Authoring and submission of (all modules – M1 to M5) of Original ANDAs, response to queries, and life cycle management of dossier.
- 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.,
- Writing Pre-ANDA meeting requests, Controlled correspondences, and pre-submission facility correspondences.
- Ensuring regulatory compliances of DMFs in connection with marketing applications.
- Compilation of SPL and eCTD, ensuring eCTD publishing activities and submission of dossier via ESG with zero validation errors.
- To keep abreast of regulatory information and registration requirements and to disseminate all such information immediately to relevant departments for appropriate change control recommendations.
- To obtain all necessary documents for the compilation of product dossiers for submission to the regulatory authorities and to ensure that information presented and submitted are complete and accepted by the respective evaluation officers.
- To develop and maintain rapport with the regulatory authority officers and to follow-up professionally and regularly on all submissions to ensure approval within agreed timeline and meeting product launch plan.
- To work with pharmacovigilance (PV) team on cases as and when required including safety queries and other significant safety information for the company. Ensure timely and accurate reporting of adverse events, safety signals, and periodic safety reports to regulatory authorities.
- Collaborate with cross-functional teams, including clinical development (if any), medical affairs, quality control, and legal, to ensure alignment and integration of regulatory, pharmacovigilance and medicolegal strategies.
- Recruit, develop, coach, and provide leadership to the RA team
- To prepare, maintain and implement necessary SOPs and processes in order to meet the regulatory requirements with respect to drug safety.
- To ensure proper and timely collection, reporting and managing of safety information of the products in accordance with regulatory requirements.
- Contribute to the development and execution of regulatory strategies for product development and post-marketing activities, including lifecycle management.
- To conduct regular regulatory training for relevant internal and external customers on awareness of regulatory ecosystem for countries assigned.
- To ensure relevant regulatory directives/circulars are attended to promptly and executed within the deadline as set by the authorities.
- Represent the company at industry conferences, meetings, and other relevant events, both at local and international level whenever required to enhance market insight/visibility
- Connect, build and establish strong relationships with key decision makers, comprising both prescribing and non-prescribing stakeholders
- Stay updated on evolving regulatory requirements, safety acts and guidelines. Perform impact assessment on products, and ensure company-wide adherence
About you
- Must possess a master's degree in pharmacy or PHD would be considered a vital asset.
- Minimum 9 years related experience in Regulatory Affairs from Pharma or Healthcare industries.
- Strong knowledge of global regulatory requirements and guidelines, including ICH, FDA, EMA, and other relevant agencies.
- Proficient in Project Management Methodologies.
- 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 using eCTD software
- Excellent mentoring, coaching and people management skills
