Senior/ Regulatory Affairs Associate

2 days ago

Singapore F. Hoffmann-La Roche Gruppe Full time

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
Senior Regulatory Affairs Associate
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
The Senior Regulatory Affairs Associate will play a key role in managing regulatory variation submissions, ensuring compliance with Health Sciences Authority (HSA) requirements, and facilitating the timely approval of pharmaceutical variations in Singapore. This role involves regulatory submission preparation, dossier publishing, regulatory intelligence monitoring, cross-functional collaboration, and regulatory tracking and documentation.
The Opportunity
Regulatory submission preparation and review involves adapting global product dossiers to meet local regulatory requirements, managing registration filings throughout the product lifecycle, and ensuring submission documents are complete, accurate, and compliant with local regulations. It includes monitoring filing status, addressing inquiries, and ensuring the inclusion of up-to-date regulatory documentation, all while ensuring timely submission and approval of regulatory filings.
Publishing involves managing the publication of regulatory dossier submissions for variations in Veeva Vault RIM, ensuring all documents are published in the appropriate electronic submission systems (e.g. eCTD, NeeS). As well as preparing and managing submission deliverables, ensuring all components are ready for publishing within set timelines, and troubleshooting technical issues related to the publishing processes.
Regulatory intelligence and updates by monitoring regulatory changes that may affect variation submission strategies and processes, while staying informed about global regulatory trends, guidelines, and policies related to pharmaceutical variations.
Cross-functional collaboration by working closely with regulatory affairs, quality assurance, commercial, clinical, and manufacturing teams to ensure timely and successful variation submissions. It also involved communicating regulatory feedback and ensuring prompt responses to health authority queries.
Regulatory tracking and documentation involves maintaining accurate records of variation submissions, approvals, and regulatory communications. This would also encompass tracking of submission status and progress, providing regular updates to internal stakeholders, as well as support internal audits and inspections by maintaining well-organized regulatory submission files.
Who you are
You should have a Bachelor's degree in Life Sciences, Pharmacy, or a related field, with 3-5 years of experience in regulatory affairs, particularly in variation submissions and publishing of dossiers within the pharmaceutical industry.
You should have experience in preparing and submitting variations and proficiency in using regulatory submission systems such as Veeva Vault RIM is a plus.
You should have a solid understanding of the pharmaceutical industry's regulatory framework, including ICH and ASEAN guidelines. You should also have strong knowledge of the local submission processes, timelines, and technical requirements.
You should be able to collaborate effectively with cross-functional teams, be able to work independently under tight deadlines and manage multiple submissions simultaneously, along with being detail-oriented, highly organized, and strong in problem-solving.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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