Manager, Regulatory Affairs APAC

Roles & Responsibilities

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

Job Description

About the role

Works closely with and have impact on: Commercial, Consultants, Distributors, QA, CRMA, Marketing

Reports to: Director, Regulatory Affairs APAC (exclude CN & JP)

Function: Global Regulatory Affairs

Role Overview

Efficiently obtaining and maintaining product registrations in APAC countries (exclude China and Japan) by working closely with distributors, consultants, regulators, HOYA affiliates. Representing RA at meetings such as life cycle management, product development, etc.

Duties and Responsibilities

• Participate in projects and provide regulatory strategy and timelines where required
• Ensure regulatory submissions are executed on-time and in a cost-effective manner
• Maintain regulatory licenses and on-time renewals to avoid supply disruption
• Adequate and effective relationship management, as well as ensuring contractual agreements are in place (where applicable) with Third Party License Holders, Regulatory Agencies, Consultants, stakeholders to meet the regulatory goals
• Ensure regulatory activities performed are in compliance with both internal and external regulations/requirements
• Support the business in obtaining timely regulatory documentation required to import/export and/or to obtain market access/reimbursement/tender approval
• Represent as Global RA lead relating to change controls initiatives/activities, providing clear communication on the proposed changes and working closely with SMEs, regional RAs to obtaining timely and accurate global RA impact assessment and formulate the global RA strategy with minimal business impact
• Prompt review and approval of promotional and marketing materials, ensure regulatory compliance with internal and external requirements
• Monitor changes in local standards, regulations, guidance documents etc. and inform the relevant stakeholders about the associated impact (where applicable)
• Provide regulatory expertise within the RA team (e.g. RA Specialists) and to other stakeholders on regulatory issues
• Oversee Global registration status and perform regulatory control for product release
• Support internal audit and follow up on the actions item (if any)
• Participate in Post market activities (e.g. AE, FSCA) where required
• Work closely with CTM on the clinical requirements where necessary
• Manage the document request portal to support global registrations

Requirements

Experience

• Minimum 5 years of APAC Regulatory Affairs experience in Medical Device Industry, especially in South East Asia, Korea, in a multi-cultural environment
• Experienced in Class 3/Class C, D general devices preferred

Skills/Accreditations

• Hands-on and in-depth technical and clinical experience in regulatory strategy, dossier preparation, regulatory submissions, queries responses
• Excellent interpersonal and communication skills
• Initiative and excellent problem solving skills
• Able to work independently with minimal supervision
• Meticulous and attention to details
• Fluent command of English, strong and effective technical writing, documentation and communication across different departments and organizations.
• Knowledge in other Asian languages would be an advantage

Academic Qualifications

• Minimally University Degree in Science (Pharmacy, Pharmaceutical Science) or related degree/diploma in Science, Engineering, and/or Biotechnology.

Travel requirements

• 10% of time in a year

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.

Tell employers what skills you have

Regulatory Compliance
Technical Writing
Regulatory Affairs
Relationship Management
Regulatory Strategy
Compliance
Product Development
Regulatory Submissions
Audit
Able To Work Independently

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