Manager, Regulatory Affairs

Description

• Primary interface to and from the RA personnel in the affiliates.
• Primary interface with local health authorities via RA personnel in the affiliates.
• Primary RA interface with Commercial. Represent RA on area brand teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
• Implements Area Regulatory Strategic Tactical Plan for assigned projects for countries in JAPAC region in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
• Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met.
• Maintains, monitors and provides input on the regional regulatory environment and policies to understand new regulations, assess implications to the business, develop and execute strategies to respond to the regulations.
• Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products.
• Actively supports affiliate regulatory in securing timely approval of registrational clinical trials.
• Actively participates in training programs and other area regulatory initiatives for JAPAC affiliates.

Qualifications

• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 8-10 years’ experience in Regulatory. At least 3 years’ experience in JAPAC regulatory affairs. Have knowledge of the regulatory requirements of the countries within the JAPAC region
• Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful.
• Experience in clinical development and clinical trial submissions is preferred.
• Proven interpersonal skills.
• Strong proven personal development and motivational skills.
• Proficiency in communicating strategic and tactical issues to management.