International Regulatory Affairs Manager

**_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...

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...

**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...

**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...

**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...

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...

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...

**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...

**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...

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...

**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...

**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 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...

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...

**Job Title**: Regulatory Affairs Specialist Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique...

Public Affairs Manager is responsible to posiiton DLMI as the Government and communities’ preferred dairy partner to grow access to nutrition. What we ask - Bachelor's degree or equivalent preferably in Public Affairs, Laws, Economics, Business, or any other relevant fields - Minimum 8 years of relevant working experience - Strong written and spoken...

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...

Prepare, review, and submit dossiers to regulatory authorities for registration of medical devices. - Attend to queries posted by regulatory authorities in timely manner. - Review labelling and marketing materials to ensure compliance with relevant regulatory requirements. - Collecting, coordinate, evaluating and compile data and documents in a variety of...