Regulatory Affairs Manager, Asia

PRODUCT COMPLIANCE TO LOCAL REGULATIONS:

• Manage the regulatory activities across Southeast Asia region - regulatory submissions, ensure compliance for new or existing products.

• Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and guidelines.

• Manage the preparation of regulatory submissions, including product registrations, licenses, and approvals for new and existing products.

• Draft, revise and review the relevant submission documents.

• Provide regulatory guidance for the labelling, formula compliance, advertising and marketing of new and existing products across Southeast Asia region sales channels.

• Conduct regulatory assessments and evaluations of product formulations, labelling, and promotional materials to ensure compliance.

• Review raw material and ingredient compositions for regulatory conformity based on industry guidelines.

• Participate in the design of new product launches by providing regulatory expertise on product formulation, package design, labelling, and claims development, etc.

• Create and/or update document standard operating procedures regulatory activities.

• Develop and implement procedures for creating, reviewing and approving labels to ensure consistency in labelling in the Southeast Asia markets.

• Support product notifications as per business needs ensuring supply continuity.

MANAGING EXTERNAL REGULATORY/ GOVERNMENT BODIES/ CUSTOMS:

• Provide responses to regulatory agencies regarding product information or issues.

• Assist with activities such as audits, regulatory agency inspections, or product recalls.

• Develop relationships with various regulatory agencies, as required.

• Assist with investigations relative to product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

• Manage and track labelling projects across Southeast Asia region, including a system to provide access to important documents to external stakeholders.

• Assist in creation of responses to regulatory agencies regarding product information or issues.

• Securing documentation from various government agencies across the Southeast Asia region on an as needed basis.

• Create product certificates and product documentation for product notification/registration where necessary.

• Act as a HSA Agent for a foreign establishment to (a) review, disseminate, route, and respond to all communications from HSA including emergency communications; (b) respond to questions concerning those drugs that are imported or offered for import to HSA; (c) assist HSA in scheduling inspections; and (d) If HSA is unable to contact a foreign registrant directly or expeditiously, HSA may provide the information and/or documents to the HSA agent. HSA’s providing information and/or documents to HSA agent is equivalent to providing the same information and/or documents to the foreign registrant.

• Attend project meetings at early or late time of the day to accommodate external clients or internal customers located at different time zones.

• Communicate with client/sponsor as needed.

NEW PRODUCT INTRODUCTION SUPPORT:

• Involvement in project implementation from regulatory perspective for new product introductions.

• Support relevant team on creating new product pipelines and launches products according to project timelines.

• Work closely with cross functional teams to ensure required documentation and compliance evaluations are in place for successful product registration/notification and launch.

• Provide regulatory guidance to departments or development project teams regarding appropriate subjects.

CONTINUOUS IMPROVEMENT:

• Stay abreast of changes in regulatory requirements and industry trends to proactively advise the company on regulatory matters.

• Maintain current knowledge of relevant regulations, including proposed and final rules.

• Provide training session to the global RA team of Southeast Asian Regulations related to drug registration.

• Maintain good relationship with other functional departments.

• Key Challenges and Success Measures Customer, Stakeholders and Sourcing Site Regulatory Collaboration: Communicate regulatory information to cross-functional teams and ensure that information is interpreted correctly.

• Extend support to customers in case of product clearance/customs as needed.

• Provide accurate, risk-based approach to regulatory queries.

• Positively add to the culture of the organization and participate across the broad spectrum of activity the function is responsible for to deliver on the total organizational goals.

• Responsive to stakeholders.

• Assist routine management of RA department or temporary works assigned by RA Director.

REQUIREMENT:

• Familiarity with relevant regulatory guidelines and standards.

• Possess good knowledge of local and Southeast Asia regulations, inclusive HSA, USFDA, TGA, etc guidance.

• Good interpersonal and communication skills.

• Good organization and coordination capability, characterized with sense of responsibility, acceptable and adaptable to work pressure, endurable to hardship.

• Bilingual in both English and Mandarin (including read, speak and write).

• A good team player with positive learning attitude.

• Independent, meticulous, detail-oriented, and proactive.

• Detail-oriented with the ability to manage multiple projects and deadlines effectively.

• Ability to work collaboratively in a team environment and communicate effectively with internal and external stakeholders across multiple time zones and cultures.

• Strategic thinker with the capability to adapt to changing regulatory landscapes and business needs.

• Results-driven mindset with a commitment to upholding high ethical and professional standards.

• Strong management skills.

• Strong ability to research, analyse, problem solving and project management.

EDUCATION & EXPERIENCE:

• Experience of 5 years or above of drug development and/or related experience in pharmaceutical/biopharmaceutical/medical, and 3 years or above on working with regional / country specific regulatory bodies, customs, regulatory consultants, etc.

• At least bachelor’s degree studies from an accredited college/university, preferably in Medicine/Pharmacology/Pharmacy/Chemistry/Pharmaceutical Sciences discipline or related field.

• Preferably holds a valid Pharmacist license with Singapore Pharmacy Council.