Job Description

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JOB SUMMARY

The job requires the person to manage Regulatory Affairs for all Company products to ensure they are in compliance with statutory and company requirements and maximize the contribution of Regulatory Affairs to the achievement of business objectives through active assistance in the development and implementation of the company\xe2\x80\x99s policy positions and product advocacy strategies.

KEY RESPONSIBILITIES & ACCOUNTABILITIES

Regulatory Affairs

• Plan, strategize and monitor regulatory filings for timely submissions and approvals of new product registrations and variation applications.
• Life cycle management of existing product portfolio while ensuring smooth supply of products
• Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
• Build effective working relations with the regulatory agency and follow-up closed on approval of products registration and variations
• Work with all appropriate local functions to develop and implement the best regulatory strategies/plans to support commercial goals and product launch excellence.
• Develop annual regulatory budget for Singapore filings/variations/registrations/license renewals.
• Review promotional material in relation to product campaign launches and ongoing product marketing activities.
• Support regulatory review or artwork/promo material/ad-hoc requests for partners\xe2\x80\x99 products
• Update and maintain local and global-associated databases with Malaysia & Singapore regulatory information.
• Keep tracking of policy changes, current and emerging issues, understand their potential impact on business and build corresponding strategies to support business
• Develop and maintain good and effective relations with local authorities and pharmaceutical associations
• Participate in local authority inspections and internal audits when applicable to the regulatory affairs function.
• Assist Head of Regulatory Affairs, MYSG on regulatory assignments as and when required.

Specific Competencies

• Highly organized and self-disciplined
• High level of integrity and good morals.
• Innovative and resourceful with excellent analytical and problem-solving skills
• Excellent communication and facilitation skills
• A good team player with excellent interpersonal skills
• Excellent written and oral communication skills in English

QUALIFICATION / ATTRIBUTES

• Bachelor\'s degree or professional qualification, preferably with major in Life Science, Pharmacy, Biotechnology or a related technical field
• A minimum of 5 to 7 years years of relevant Regulatory Affairs expertise in the pharmaceutical industry
• Experience in covering both Malaysia and Singapore will be an added advantage
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
• Knowledge of national legislation and regulations relating to medicinal products
• General awareness of the registration procedures/challenges in the country for CTAs, MAs and all lifecycle management activities.

Locations

Selangor, Malaysia

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Takeda