Regulatory Affairs Expert job opportunity at Roche.

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DatePosted 8 Days Ago bot
Roche Regulatory Affairs Expert
Experience: 2-years
Pattern: full-time
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degreeMaster's (M.A.)
loacation Hanoi, Vietnam
loacation Hanoi....Vietnam

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position We advance science so that we all have more time with the people we love Your Opportunity Carry all regulatory affairs responsibilities and activities for assigned products at local affiliates with high compliance standards. Collaborate with both internal cross-functional team members, as well as with external stakeholders to achieve objectives. Understand Roche Pharma Vietnam & IDT vision & shared goals and translate it into clear prioritized objectives for regulatory.  Plan and implement registration strategies to assure business continuity and support business Gather, analyze and communicate internal and external regulatory intelligence Develop innovative, risk-based registration plans and submissions strategies for responsible products with guidance from RA Chapter Lead Embed themselves in Integrated Disease (IDT) Teams and represent regulatory function on providing regulatory expertise and input in cross-functional meetings to co-create ways to achieve rapid and continued access to medicines. Execute and manage all regulatory filling activities (incl., Brand name or reference biotech products) across product lifecycle. It includes the new registration/ extension/ TRIC/ CDS update/label update or any other variations/ corrections.  Initiate regulatory filings aligned with business and supply needs to assure business continuity. Monitor and communicate all regulatory filings status and respond to internal and external questions. Ensure timely regulatory filings submissions and approvals. Influence internal and external stakeholders for successful regulatory outcomes. Manage Affiliate regulatory activities on relevant Roche systems: Global: GPRS, interface portal, Q&A interface portal, CPP system, COREMAP, etc. Local: Touchpoint, Google Share Drive, Report, etc. Manage product information updates with respect to Roche and local regulatory requirements and for Roche databases  Ensure up-to-date and accurate information in all related systems, reports. Develop and maintain current knowledge of international requirements and local regulations. Ensure regulatory inspection-readiness for the Affiliate, as per assigned responsibilities Ensure regulatory compliance for product released to market according to marketing authorizations Control, manage and develop the regulatory data with timely updates for additional/ changes (e.g Record Decision, MA, approved PIs & artworks; approved indications...  CPP, GMP, trade mark certificate, power of attorney, plant master files of manufacturing for assigned products) Who you are Must-have University degree in Pharmacy/ Medical At least 2 years of experience in the RA role in MNC pharmaceutical companies. Fluency in written and spoken English and Vietnamese Proficient in basic computer software/ applications Functional competencies describe the specific knowledge, skills and capabilities needed to be successful within the role and prepare for a future role within International Affiliate DRA Highly organized, with the ability to prioritize own tasks as well as those of others. Good planning skills Builds trustful and effective relationships with stakeholders Good practical experience of contacts with Health Authorities and local partners Commitment to performance measures of time, cost and quality Takes responsibility, drives results and achieves expected outcomes. Meticulous with an eye for details.     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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