Quality & Regulatory Affairs Specialist

Job description

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 PositionTitle position : Quality & Regulatory Affairs Specialist Reporting Line : Regulatory and Quality Affairs Leader Location : Taguig City, Roche Philippines (Diagnostics Division) The Opportunity: Accountable for quality and regulatory affairs for Roche Philippines (Dia and NPC), with support from Regulatory and Quality Affairs Leader and senior peers, in which the incumbent has to implement and perform activities necessary to ensure compliance with local regulation requirements and Roche Global Quality principles, policies and standards. As the Quality & Regulatory Affairs Specialist, you are responsible for: Prepares for health authority inspections by assuring the affiliate is operating in an “inspection ready” manner at all times Monitors new regulations and provides impact assessment with respect to RDPH operations assisting the RA manager Participates in the industry association to keep abreast of regulations and promote Roche position on regulatory issues Coordinates with Global regulatory associates, prepares regulatory dossiers, submits and monitors new and existing registrations. Recommends strategies for earliest possible approvals of applications. Manage product licenses during the product life-cycle and ensure license to operate Submit and review promo applications and maintain promo permits to make sure seamless business continuity Support regulatory activities to meet product sustainability and compliance with chemical registrations Manages Affiliate Notifications; Safety Board Notifications (SBN) and Quality Notifications (QN) in a timely manner Approve release incoming RBR(Repackaging Batch Record) Assist in creating artwork for labelling and suppliers’ work instruction Guide and support internal stakeholders to comply with regulatory and quality requirements Perform various regulatory and quality activities required for organizational operations Who You Are: Pharmacy Degree or Bachelor's Degree in relevant field is preferred. Ideally minimum of 2 years industry experience in the Medical Devices is preferred. Who we areA 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.