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The Position A healthier future. It is 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. That is what makes us Roche.
The Quality & Regulatory Affairs Specialist is responsible for securing and maintaining product registrations from Philippine FDA and other relevant product-related regulatory approvals. The role is also responsible for monitoring new regulations and supporting the Quality & Regulatory Affairs manager in ensuring that the company is able to comply with new requirements. Moreover, the role should ensure compliance with local labeling and promotional material requirements.
Key responsibilities include; Prepares for and manages health authority inspections by assuring the affiliate is operating in an "inspection ready" manner at all times.
Coordinates with Global regulatory associates, prepares regulatory dossiers, submits and monitors new and existing registrations. Recommends strategies for earliest possible approvals of applications.
Submit and review promo applications.
Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
Monitors new regulations and provides impact assessment with respect to RDPH operations.
Creates and maintains Promotional Communication content approval procedures to ensure compliance with Roche standards and applicable laws and regulations. Approves product promotional communications.
Participates in the industry association to keep abreast of regulations and promote Roche position on regulatory issues.
Promote awareness and participation to Security, Safety, Health and Environmental Protection policies and programs at site to create a safe work environment to all employees.
Ensure full compliance with applicable regulatory requirements and perform activities following global Roche quality standards and local SOPs.
Who you are: B.S. Pharmacy / B.S. Medical Technology, with valid PRC License
1-3 years of experience in regulatory affairs in a multinational IVD/Medical Devices/Pharmaceutical Company
Project management experience is preferred
Proficient in English (spoken & written)
Computer Skills (Google Applications, MS Excel)
Excellent interpersonal and communication skills
Self-Initiative and Proactive, values continuous improvement
Critical thinking skills and able to manage complex regulatory issues.
Good project management skills and able to drive and deliver registration goals with minimum supervision.
Able to develop and maintain a good network across multiple levels within the organization as well as externally.
Able to influence, manage and make sound recommendations to all stakeholders.
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Roche is an equal opportunity employer.
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.
