Job Description

The Position Summary Responsible for leading and overseeing the oversees development and execution of regulatory strategies, regulatory projects, regulatory submissions and associated activities to ensure rapid and optimal registration for all new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products. The incumbent also acts as the Affiliate Quality Head (AQH), Deputy Local Safety Officer (LSO) for Diagnostics, and Deputy Local Regulatory Safety Officer (LRSO) for Diabetes Care. Essential Duties and Responsibilities: include the following (other duties may be assigned) 1. Regulatory Role a. Submissions: i. Acts as applicant and owner of the submissions process. ii. Acts as primary contact for the local Regulatory Authority regarding registration of products distributed by Roche Diagnostics and Diabetes Care in the country. iii. Informs the local organization (i.e. Logistics and Marketing), on registration status of Roche Diagnostics and DC products to ensure legal import and distribution. iv. Plan, monitor and track regulatory submissions. b. Regulatory Intelligence: i. Provides timely feedback to the Global Regulatory Submissions Affiliate Coordinator and the BA/BU/GPS Regulatory functions on changes to local regulatory requirements. ii. Cooperates with Global Regulatory Submissions and local manufacturer associations to influence registration requirements. iii. Provides information and interpretation regarding regulatory requirements to the Global Regulatory Submissions Affiliate Coordinator and BA/BU Regulatory functions needed to develop Regulatory Strategy, Clearance Plans and Regulatory opinions c. Local Regulatory Processes: i. Provides Regulatory training to employees as required to meet compliance with local laws and regulations. ii. Specifies requirements for local labeling of Roche Diagnostics and Diabetes Care products. d. Ensures compliance with Roche and Local promotional requirements, and Regulatory Divisional Standards 2. Affiliate Quality Head (AQH) a. Responsible to ensure that the site complies with applicable RD Quality Standards and local regulatory requirements. b. Training and communication: i. Responsible for Affiliate adoption, training, and implementation of local processes in accordance to the applicable Divisional Standards. ii. Ensures appropriate Quality Management- related processes are in place, communicated, and that relevant employees are adequately trained. iii. Serves as local contact for GQC and as the Affiliate conduit for sharing of information related to Quality Management. c. Monitoring of Q&R Metrics Updated 09 March 2020 | Page 1 of 3 Roche (Philippines) Inc Diagnostics Division
i. Monitors and assesses Key Performance Indicators (KPIs) as defined by Global Q&R and ensures that the Leadership Team is informed and corrective actions are taken if needed. d. Notifications: i. Notifies the Head Global Quality and Regulatory (Q&R), the Head of GQC, applicable Heads of Quality (according to the quality management system being inspected), and the Global Regulatory Counsel of any Regulatory Authority inspections and the final report/outcomes thereof (e.g. FDA or other Regulatory Authority). Notification must occur immediately upon notification by (pre-announced), or arrival of, the Regulatory Authority, as applicable; ii. Notifies the Head of Global Q&R and Head of Regulatory Submissions of any communication from a Regulatory Authority of a compliance issue that could lead to a regulatory/enforcement action; iii. Notifies the Head of Global Q&R and Head of Regulatory Submissions on receipt of a Non-Approvable or Not Substantially Equivalent ("NSE") Letter or equivalent from FDA or other Regulatory Authority regarding a product submission; iv. Notifies the Head of Global Q&R and Head of Regulatory Submissions about Class I or II corrections or removals (e.g., recall) of products; v. Notifies the applicable Heads of Quality about incidences of, or investigations into, significant issues that could lead to a correction or removal; vi. Notifies the applicable Safety Board Chair upon receipt of communications from Regulatory Authorities related to a product quality or safety issue. vii. Notifies the Head of GQC about any communications from a Regulatory Authority of compliance or safety issues that implicate the DQS. e. Internal/ external audit i. Ensures internal audit and external audit of suppliers is performed as applicable based on Divisional/ Diabetes Care standards 3. Deputy Local Safety Officer (LSO) for DIA and Local Regulatory Safety Officer (LRSO) for DC a. Supports the LSO for DIA and LRSO for DC in performing their duties with regards to Safety Board/ Recalls and Customer Notifications and Complaints Reporting to Country Manager Supervisory Responsibilities

• Quality and Regulatory Associate (DIA)
• Quality and Regulatory Associate (DC)

Liaises with FDA, DOH, DENR, MDI and other government agencies that may apply PAMDRAP and other relevant Industry Associations

• Local Diagnostics and Diabetes Care Leadership Team
• Relevant internal team members including Sales, Marketing, Finance, Supply Chain, and other departments/areas as required
• Regional and global Q&R functions or other departments as required

Updated 09 March 2020 | Page 2 of 3 Roche (Philippines) Inc Diagnostics Division
Education and/or Experience

• Bachelor’s/Master degree in Pharmaceutical or Science related field (preferably medical laboratory related).
• 3-5 years of experience in regulatory affairs in a IVD/Medical Devices/Pharmaceutical Company

Language Skills Proficient in both English and Filipino (written & spoken) Other Skills and Abilities

• Strong analytical skills and able to manage complex regulatory issues.

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. Willing to travel
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.