Novugen Hiring! Full Time Senior Executive, Regulatory Affairs in Selangor - Ricebowl

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

To support Novugen's international business expansion by preparing, coordinating and maintaining regulatory submissions for pharmaceutical products across international markets, excluding the United States and Malaysia.

The role is responsible for ensuring regulatory dossiers, product registration applications, lifecycle submissions and related documentation comply with applicable local regulatory requirements and support timely product approvals and commercialization.

The incumbent will initially support dossier preparation, submissions and regulatory lifecycle activities under guidance and eventually independently manage assigned product registrations and regulatory projects.

Key Responsibilities:-

1. Regulatory Dossier Preparation & Product Registration

• Prepare, compile and review regulatory dossiers for product registration applications in international markets, including CTD, ACTD and other applicable formats.
• Coordinate the preparation of regulatory submissions, ensuring completeness, accuracy and compliance with country-specific regulatory requirements.
• Review and compile technical documentation received from R&D, Quality, Manufacturing, Analytical, Clinical and other relevant functions.
• Ensure submission documents are aligned with applicable regulatory guidelines and requirements of the respective health authorities.
• Support the preparation and submission of new product registrations to facilitate timely product approvals and commercialization.

2. Regulatory Lifecycle Management

• Manage regulatory lifecycle activities for registered products, including variations, renewals, amendments and other post-approval regulatory submissions.
• Coordinate responses to regulatory queries and ensure timely submission of accurate and complete responses.
• Monitor regulatory submission status, approval timelines and outstanding regulatory requirements.
• Maintain regulatory records, product registration documents and submission trackers to ensure accurate and up-to-date information.
• Support regulatory activities related to product launches, market expansion and commercialization.

3. Regulatory Compliance & Documentation

• Review technical and supporting documents for regulatory compliance, including product specifications, analytical methods, stability data, manufacturing processes, validation documents and product labelling.
• Ensure regulatory submissions are aligned with applicable pharmacopoeial requirements and relevant international regulatory guidelines.
• Review product information, package inserts, patient information leaflets and artwork to ensure compliance with local market requirements.
• Support regulatory assessments of change controls and deviations to determine potential regulatory impact and submission requirements.
• Ensure regulatory documentation is maintained in accordance with applicable regulatory requirements and internal procedures.

4. Regulatory Intelligence & Market Requirements

• Monitor changes in regulatory guidelines, registration requirements and submission procedures across assigned international markets.
• Conduct regulatory research to identify country-specific requirements for product registration, lifecycle management and product commercialization.
• Provide regulatory input and guidance to internal stakeholders on registration requirements and regulatory pathways.
• Coordinate with local regulatory agents, distributors, consultants and other external stakeholders to clarify regulatory requirements and facilitate submissions.
• Support regulatory feasibility assessments for new products and potential international markets.

5. Regulatory Coordination & Stakeholder Management

• Coordinate with internal stakeholders, including R&D, Quality, Manufacturing, Supply Chain, Business Development and other relevant functions, to obtain required regulatory documentation.
• Follow up on outstanding documents, regulatory queries and submission requirements to ensure timely completion of regulatory activities.
• Maintain effective working relationships with local regulatory partners and external stakeholders.
• Provide regular updates on registration progress, approval timelines, regulatory risks and outstanding issues.

6. Additional Responsibilities

• Support regulatory projects and initiatives related to international business expansion.
• Identify opportunities to improve regulatory submission processes, documentation quality and operational efficiency.

About You

• Bachelor’s degree in pharmacy, Life Sciences, or a related scientific field.
• 3-5 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.