Lead, Regulatory Affairs

Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to accelerate Regulatory approvals for new medicines in International markets as efficiently and effectively as possible so that no...

Biocare Group is a leading pharmaceutical company committed to improving global health through the development and commercialization of innovative healthcare products. With a strong focus on research and development, Biocare Group aims to provide safe and effective treatments for patients worldwide. **Summary** We are seeking an experienced and highly...

**Tasks & responsibilities** - Oversee the Regulatory Affairs division, providing leadership and guidance to a team of regulatory professionals. - Collaborate with cross functional teams, including R&D, Quality Assurance, Clinical Development, and Manufacturing to ensure regulatory compliance throughout the product lifecycle - Act as the primary point of...

**Location**:Petaling Jaya, MY, MY**Job Function**:Client and Customer Services**Requisition Number**:149489**Description**: **Job Summary** - **Responsible for providing regulatory expertise to Business Unit Healthcare, DKSH Malaysia Sdn Bhd, and for ensuring the company’s Pharmaceutical and Medical Device operations are in compliance with the...

**_Are you a strategically focussed Regulatory professional with international experience and would like to play an integral part in bringing life changing medicines to patients? If you are please read on._** At AstraZeneca, we make a difference every day by delivering life-changing medicines to millions of people globally. Creating a more agile and...

**Position Summary** - The Regulatory Submissions Professional is a member of the Local Operating Company Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management Centre (RMC), and this...

Regulatory Affairs Specialist **Petaling Jaya, Malaysia** **Regulatory Affairs** **Hybrid** **Full-time** - The Regulatory Affairs Specialist is responsible for a range of regulatory activities and will be involved in several regulatory operations projects. Acting as an expert, you contribute to shaping the regulatory landscape and concepts of...

Education : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...

**Location**:Petaling Jaya, MY, MY**Job Function**:Client and Customer Services**Requisition Number**:155287**Description**: **Job Summary** - Assist Senior Pharmacist, Regulatory Affairs to cover regulatory affairs matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare **General Responsibilities** - Assist in timely product registration and variation...

Job Description Review, prepare, compile and submit all documentations required for medical device submissions, license renewal, new device registrations and change notifications with relevant regulatory agencies Manages and implements internal regulatory tracking/ control systems Keep abreast of regulatory requirement and changes Liaise with regulatory...

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix...

**Essential Job Duties and Responsibilities** The Regulatory Submissions Professional is a member of the Local Operating Company Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life cycle management submissions are under the scope of the Regulatory Management...

Degree in Science - At least 1-2 years working experience in Regulatory Affairs with MNC Pharma environment - Meticulous, independent and organize **Responsibilities**: - To ensure proper life-cycle management of product (eg.timely variation submission and follow up till approval, renewal of product licenses & updating of all relevant regulatory...

**Position Summary**: - Assisting AD RA or equivalent to provide guidance and leadership to the team in terms of - Ensure compliance to company SOP and Quality Management System. - Lead the team with a talent development mindset and adhering to principles of DE&I - This role is responsible for regulatory activities to support and grow the business in line...

Responsible for all regulatory matters with regard to implementation of all regulatory aspects, product registration, compliance with rules and regulations. - Implementation of Regulatory target, prioritize set, conduct and report on the agreed development program for the company in order to obtain new product registration and revamp registration in the...

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunity to go beyond your comfort zone in order to grow personally...

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunity to go beyond your comfort zone in order to grow personally...

**Essential Functions**: Government Affairs - Develop and maintain relationships with government officials, regulatory bodies, and relevant stakeholders. - Monitor and analyze government policies, regulations, and legislative developments affecting the company. - Advise internal teams on government affairs strategies to ensure compliance and mitigate...

Responsible for planning strategically to obtain marketing approvals at the earliest possible date and manage the provided resources to assure that the goals of Abbott Diabetes Care Malaysia are achieved while ensuring full local regulatory and company compliance. To monitor and ensure release for sale of product conforming to Abbott regulatory and quality...

Regulatory affairs managers are in charge of regulatory and legal affairs in several sectors such as the healthcare, energy and banking industries. They oversee the development of products and services from inception to market release by making sure everything complies with the local legislation and meets regulatory requirements. They have experience in the...