Job Description

To assist regulatory staff in renewal and maintenance of Product Registration Licenses in Malaysia and Brunei via a Third-Party Agent. To assist regulatory staff for Life-Cycle Management of all registered products in Malaysia & Brunei such as PI/PIL Update, Artwork Changes, CMC Changes, Change of Sites, New Indications & Dosages Variations, and all other changes that affect the registered information within Regulatory Authorities in Malaysia & Brunei. To assist regulatory staff for all matters pertaining to the registered products including archiving and retention of the product files. Responsibilities: To protect the company\xe2\x80\x99s reputation and license to operate:

• Comply with relevant national, regional and global legal and ethical requirements.
• Model and encourage right-first-time-culture and quality in all activities (patient at the center of what we do).
• Ensure that clear accountability is established throughout the organization for delivering and ensuring compliance with all relevant company policies, local laws, regulations, permits and company Global EHS Standards.
• Ensure that discipline and enforcement mechanisms are in place to deal with intentional breaches of EHS by reporting EHS non-compliance, unsafe acts, unsafe conditions and negligence in implementing EHS requirements to the EHS Lead.

To ensure that our medicines reach patients in compliance with the dossier reviewed and approved by the regulator:

• Implement, maintain and execute robust controlled regulatory processes.
• Apply Accelerated Delivery Program (ADP) ways of working in line with the expected company fundamentals of delivery.
• Demonstrate high performance attitude by delivering against objectives, targeting, effectively measuring and tracking delivery and implementing appropriate course correction as required.

To build effective internal relationships to become a true and valuable partner for key stakeholders:

• Establish and enhance relationships with key business partners, e.g. Medical, Commercial, Quality, Supply Chain, Market Access and Government Affairs.
• Develop quick, flexible and effective regulatory solutions for emerging issues to support the business.

To drive growth and access to medicines through innovative and effective regulatory solutions:

• Continuously adapt current ways of working and develop new ones to reflect business needs or changes in the legislative or regulatory environment.
• Demonstrate solution driven and \xe2\x80\x98Thinking-Out-Of-The-Box\xe2\x80\x99 attitude in addressing opportunities and resolving challenges.

To give the company competitive advantage in highly complex and fast changing environment:

• Demonstrate robust knowledge and practical experience of all fundamental regulatory processes.
• Know the key stakeholders, the organization, tasks, requirements and ways of working of the Health Ministry, Regulatory Authorities and other relevant Bodies (e.g. Medical Device Authority).
• Keep up-to-date knowledge of the healthcare environment, the political, legislative and regulatory framework and the pharmaceutical industry including the competitor landscape.

Requirement:

• Preferably candidate with Bio / Medical Sciences / Management / Technical background.
• Professional written and verbal communication skills.Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.
• Ability to deliver clear communications and foster excellent working relationships with peers and
• management.
• Ability to self-motivate and be resilient and focused under pressure.
• Flexible thinking \xe2\x80\x93 able to challenge and see views from different perspectives.
• Good team player \xe2\x80\x93 works well in cross-functional teams

Job Type: Permanent Salary: RM2,500.00 - RM2,800.00 per month Schedule:

• Monday to Friday

Supplemental pay types:

• Commission pay