Senior Executive, Regulatory Affairs

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Novugen 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 experience in venturing into strategic healthcare businesses and the development of world-class healthcare facilities around the globe. We bring hard-to-source and technology-intensive products to the market.

Our manufacturing facility in Bandar Enstek, Negeri Sembilan is the FIRST USFDA-approved pharmaceutical manufacturing facility in Malaysia and the only one in Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from API to Finished Products R&D and manufacturing.

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 strive to innovate new concepts to accelerate the launch of pharmaceuticals 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 markets. Through our passionate teams and continuous investment in R&D, we aim to provide early access to affordable medicine of the highest quality. This is our commitment to change lives worldwide.

About the role

Senior Executive, Regulatory Affairs is responsible for managing the dossier filing for the International Market for solid oral dosage forms.

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 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.
• 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.
• Writing Controlled correspondences (standard and complex) correspondences.
• Thorough understanding of USP and EP requirements while reviewing the specification and keep updating the team with the current requirements.
• Review and compilation of relevant sections 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 stakeholders 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 and eCTD, ensuring eCTD publishing activities and submission of dossier via ESG with zero validation errors.
• Regulatory Monitoring of Approved Products.

About you

• Preferably to have a bachelor’s degree in pharmacology or equivalent.
• Minimum of 5 years’ related experience from Pharma and Healthcare industries, specifically in Regulatory Affairs.
• Proficient in Microsoft Office Suite.
• Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission, and maintenance of Generic products in the ASEAN countries.
• 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.
• Ability to learn quickly on new regulatory markets.
• Ability to communicate effectively, negotiate, and persuade.
• Ability to work on multiple projects at the same time.
• Ability to keep tight deadlines and work under pressure.
• Flexibility and ability to adapt to change.
• Scientific rigour, attention to detail, meticulousness.
• Sound judgment in applying regulatory requirements.
• Diplomacy & ease in establishing and maintaining interpersonal relationships.