Regulatory Affairs Specialist

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...

**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...

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...

**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...

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...

**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...

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**: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...

**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...

**_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...

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...

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...

**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...

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...

**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...

**Job Purpose** To manage medical affairs concerning the specialist doctors practicing here including recruitment of specialist. **Duties and Responsibilities** **Recruitment of Doctors** 1. To actively recruit new consultants for the hospital, in line with the hospitals requirements. 2. To use the National Specialist Register as a guide to source for...

Responsible for recruiting new specialists to join Beacon Hospital. - Adhere to all quality standards and processes, for the recruitment & retention of consultants. - Work on the consultant's privilege procedure. - To be market sensitive and constantly gather market intelligence. - Prepare and provide Ad-hoc reporting and analysis metrics and reporting. -...

Support regulatory compliance activities include product assessment and its approval, label review - Working with the chemical and cosmetic regulations in Singapore and Malaysia and collating regulatory development - Support all regulatory relevant issues from business unit, customer or custom - Manage regulatory database and documentation to ensure it is up...

**Your role at HEINEKEN** In this role, you will: - Develop and implement strategic plans to build and sustain cordial and long-term relationship with key Government stakeholders. - Engage national and local legislators and regulators on policy and regulatory matters that impacts HEINEKEN’s business. - Monitor, analyse and interpret developments in...

The Patient Safety Specialist is an appropriately qualified person for pharmacovigilance who contributes to the core components of the local pharmacovigilance system, thus ensuring AZ have in place an effective pharmacovigilance system that complies with the legal pharmacovigilance requirements. Core responsibilities may include: - Supporting activities...