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.