Associate Regulatory Affairs Manager

Job Purpose

• To hold the Pharmacist Poison License Type A for the company to operate in Malaysia ;  and other licenses where appropriate [applicable for registered pharmacists only].
• To register Pharmaceuticals, Vaccines, Biologics, Biotechnology products and Medical Devices in Malaysia & Brunei.
• To renew and maintain Product Registration Licenses in Malaysia and Brunei. For Brunei,it is via a Third-Party Agent.
• Perform 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 be the custodian for all matters pertaining to the registered products including archiving and retention of the product files.
• To create and approve artworks in Artwork Management System.
• To ensure the created and approved Artworks for Market Specific Pack (MSP), Shared Pack, Multi Market Pack, General Export Pack (GEP), and all other Supplied artworks are in compliance with relevant national, regional and global labelling requirements.
• To ensure compliance to QMS processes and Artwork Management SOP for Pharma and Vaccines.
• To ensure timely revision of SOPs for compliance to the current regulatory requirements.

Key Responsibilities:

1. To protect the company's reputation and license to operate

• Comply with relevant national, regional and global legal and ethical requirements.
• Implement GSK regulatory governance principles and internal control framework.
• Model and encourage right-first-time-culture and quality in all activities (patient at the center of what we do).
• Proactively identify gaps in processes and mitigate them adequately or escalate.
• Continuously develop expertise, regulatory and artwork management knowledge through Training Curricula, myLearning and internal and external seminars, courses and congresses.
• Ensure compliance to QMS processes and Artwork Management SOP for Pharma and Vaccines.
• Undertake timely revision of SOPs for compliance to the current regulatory  requirements.
• Effectively contribute to internal audits and external inspections.
• Provide support in crisis management and product recall.
• Foster a culture of transparency and trust by ensuring EHS responsibilities and requirements are clearly defined and communicated to staff (e.g. Policy, risks, incident reporting, emergency preparedness)
• Ensure that clear accountability is established throughout the organization for delivering and ensuring compliance with all relevant GSK policies, local laws, regulations, permits and GSK Global EHS Standards.
• Identify and manage significant EHS risks arising from the processes carried out by monitoring and reporting EHS performance via LT/RMCB meeting.
• 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.

2. 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.
• Execute all regulatory processes through thoroughly and equally timely evaluating, prioritizing, planning, making decisions and executing appropriate regulatory activities, as well as knowledge of systems and their appropriate use.
• Demonstrate high performance attitude by delivering against objectives, targeting, effectively measuring and tracking delivery and implementing appropriate course correction as required.
• Implement and monitor realistic and meaningful Key Performance Indicators (KPIs) to measure functional, individual and team compliance and performance.
• Live the spirit of Continuous Improvement and of a Learning Organization (“allow mistakes but learn from them”).
• Apply Accelerated Delivery Program (ADP) ways of working in line with the expected GSK fundamentals of delivery.
• Responsible and accountable for regulatory content of artwork in Artwork Management System.
• Responsible for creation and approval of artworks in Artwork Management System and ensuring the created and approved Artworks Market Specific Pack (MSP), Shared Pack, Multi Market Pack, General Export Pack (GEP), and all other Supplied artworks are in compliance with relevant national, regional and global labelling requirements.

3. To support GSK strategy through effective management of external stakeholders.

• Establish and enhance customer oriented and trustful relationships with Health Authorities, Regulatory Bodies, Trade Associations, Regulatory Working Groups.
• Interpret the global regulatory and policy environment when discussing with these external stakeholders as mentioned above.
• Analyze trends and anticipate future development of regulatory requirements.
• Identify opportunities and risks for the company including the competitive environment.
• Keep abreast of public health needs and expectations of the society.
• Apply GSK strategic positions and priorities effectively to shape the regulatory and political environment.

4. 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, Artwork Coordinator and Artwork Operator.
• Create a strong bridge between Regulatory and Commercial through robust strategic planning and implementation.
• Develop quick, flexible and effective regulatory solutions for emerging issues to support the business.
• Proactively identify opportunities and risks to the business in New Product Introduction (NPI), Line Extension, Market Access, Medical Device Assessment, Tender Projects, Product Packaging etc. through use of regulatory expertise and information (product knowledge, technical expertise, regulatory intelligence).
• Apply regulatory expertise and understand the value-adding role of Regulatory in strategic planning to act as a valued and trusted business partner through effective and impactful communication.

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

• Keep up-to-date knowledge of the healthcare environment, the political, legislative and regulatory framework and the pharmaceutical industry including the competitor landscape.
• 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).
• Know GxP, quality guidelines and regulations that are relevant for the pharmaceutical industry.
• Have basic medical knowledge depending on the disease area and product portfolio.
• Demonstrate robust knowledge and practical experience of all fundamental regulatory processes.
• Understand quality and supply chain principles.
• Understand the development pipeline and the product lifecycle and evaluate their impact on business, market access and medical practice.
• Have a good business acumen and informed understanding of commercial objectives.

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

• Act as a consultant to the business, offer accurate and strategic regulatory advice to support timely and informed company decision-making.
• Demonstrate solution driven and ‘Thinking-Out-Of-The-Box’ attitude in addressing opportunities and resolving challenges.
• Provide expert Due Diligence to support divestment and in-licensing activities including the development of different success routes and their opportunities and risks.
• Continuously adapt current ways of working and develop new ones to reflect business needs or changes in the legislative or regulatory environment.

Why YOU?

Qualifications & Experience

• Minimum 5 years of regulatory experience in a pharmaceutical environment with experience in pharmaceutical product artwork management.

• To have experienced working in a controlled regulatory environment and making sure that the company is fully compliant with the following Acts & Regulations :-

• Sale of Drugs Act, 1952 ;
• Control of Drugs & Cosmetics Regulations, 1984 ;
• Dangerous Drugs Act, 1952 ;
• Medicines (Advertisement & Sale) Act, 1956 ;
• Patents Act, 1983 ;
• and any other related Acts, Regulations, Directives, Policies etc. 

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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