quality and Regulatory Affairs associateRoche Pharmacutical Holding

Job Description
The Position
Summary
Responsible for overall regulatory and quality affairs for Diabetes Care, with support from Affiliate Quality Head, in which the incumbent has to implement and perform activities necessary to ensure compliance with local regulation requirements and Roche Diabetes Care Global Quality principles, policies and standards.
Essential Duties and Responsibilities include the following (other duties may be assigned):
Regulatory Affairs Specialist
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.
Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.
Monitors new regulations and provides impact assessment with respect to RDC Philippines to the AQH.
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 industry association to keep abreast of regulations and promote Roche position on regulatory issues.
Local Regulatory and Safety Officer
Establishes the local case handling process to assure quality and timely execution of product complaints and inquiries.
Conducts the training of the local personnel on complaints management.
Verifies the locally identified Potentially Reportable Incident cases to ensure proper escalation to Global and conducts local assessment of PRI cases according to local laws including reportability to authorities.
Manages Affiliate Notifications Safety Board Notifications (SBN) and Quality Notifications (QN) in accordance with DC Standards.
Supports other functions in the management of other affiliate notifications.
Performs product recall activities related to quality concerns.
Liaise with all relevant associates to ensure that any products safety issues are properly managed.
Collects and reports to Roche Global Safety all adverse events occurring in affiliate and associated with Roche products on an accurate and timely manner.
Ensures accurate and timely submission to Health Authorities of all product safety related matters, if required.
Support SSHE Officer for compliance of Roche DC to biosafety and other regulatory requirements
Deputy Affiliate Quality Head
Supports the AQH in ensuring that the site complies with applicable RD Quality Standards and local regulatory requirements such as: Training and communication, Monitoring of Q&R Metrics, Affiliate Notifications and Internal/ External audit, and Supplier Qualification.
Informs affiliate about new/updated Diabetes Care Standard/Global SOP and that, where applicable, these are incorporated into local procedures and all applicable staff is trained.
Quality Assurance
Reviews all local customization policy/working instructions to ensure compliance with the local regulatory and quality requirements.
Performs Roche QA release for repackaging batch records of locally customized products.
Prepares and submits global change requests to DC Global Change Board for local customizations.
Compliance Coordinator
Supports DC Country Head in the implementation of compliance related activities.
Coordinates compliance topics/requirement with Legal Affairs and Compliance Senior Manager
Education and/or Experience:
Bachelor Degree in Pharmacy or any course related to Roche DC products.
At least 2 years experience in a quality or regulatory role is preferred.
Multi-national companies experience is preferred.
Proficiency in both English and Filipino (written & spoken)
Other Skills and Abilities
Strong analytical skills and able to manage complex quality and regulatory issues, such as CAPAs.
Good project management skills and able to develop, drive and deliver strategic goals
Strong communicator
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.
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.