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 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 markets.
About the role
The incumbent will work with Regulatory Affairs team, cross-functional departments, including the senior management team, in developing and executing Regulatory Affairs strategies to achieve the company's objectives.
Key Responsibilities:-
- Dossier compilation for product registration and re-registration application in countries assigned.
- Timely submission of variations/amendments of registered product details as required by regulatory authorities.
- 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.
- To assist in matters related to Pharmacists roles, such as handling of scheduled-poison drugs, relevant import permit applications, etc.
- To ensure all records related to scheduled-poison drugs are appropriately maintained and well kept.
- To attend to all inhouse and external health authority and regulatory related queries, meetings, and facilitation of regulatory inspections/audits from relevant authorities, as and when required.
- 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.
Job Requirements:
- Must possess a Degree in Pharmacy, Legal, Life Sciences or equivalent. Pharmacist qualified, Good Clinical Practice (GCP) certified, Masters, MBA or PHD would be considered a vital asset.
- Minimum 9 years related experience in Regulatory Affairs and Pharmacovigilance from Pharma, FMCG, Biotechnology and / or Healthcare industries.
- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of Generic products in US.
- Strong knowledge of global regulatory requirements and guidelines, including ICH, FDA, EMA, and other relevant agencies.
- Proficient in Project Management Methodologies is an advantage.
- 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 eCTD software, Hydra and/or safety databases relevant to pharmaceutical or healthcare industry etc.
- Scientific rigor, attention to detail / meticulous.
- Excellent mentoring, coaching and people management skills.
- Strong intrapreneurial skills and mindset from start up to established organization.
- Versatile and resilient, ability to stay positive in high-pressure and ambiguous environments and work towards delivering results.
