Regulatory Affairs Associate Manager
5 months ago
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 of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
**What You Do**
- Support in the regulatory affairs strategy and submission of biopharmaceutical and medical devices in Malaysia.
- Coordinate with the APAC Regulatory Hub of regulatory tasks and assist in the update, enhancement & creation of internal procedures.
- Interpret, communicate regulatory expectations, develop strategies and risk assessments to internal & external stakeholders in order to execute and achieve submission timelines in compliance with applicable regulations.
- Manage all communications with the Health Authorities.
- Support country & commercial strategy with insights from regulatory intelligence.
- Manage relationships & have fluent communication with third parties, cross-functional stakeholders & other partners to attain performance & identify or solve problems that arise & are critical within the submission processes.
- Participate in business meetings with cross-functional teams & external customers and provides active and ongoing guidance within submission projects.
- Review and release of promotional materials according to local regulations and corporate policies, as needed.
- Review and release of artworks according to local regulations and corporate policies, as needed.
- Active participation in regulatory associations.
- Conduct trainings to enhance teams’ knowledge of working in a regulated environment. Support other activities as per business need.
**Who You Are**
- Bachelor's degree holder with more than 5 years regulatory experience
- Know-how in Malaysia regulatory requirements for pharmaceutical products and medical devices.
- Excellent English and Malay verbal and written communications skills
- Ability to interact effectively with all levels of management.
- Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.
The position will report to APAC RA Hub Regional Regulatory Affairs Manager.
**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
-
International Regulatory Affairs Manager
5 months ago
Petaling Jaya, Malaysia AstraZeneca Full timeWithin 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...
-
Manager Regulatory Affairs
5 months ago
Petaling Jaya, Malaysia DKSH Full time**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...
-
Regulatory Affairs Specialist
5 months ago
Petaling Jaya, Malaysia Johnson & Johnson Full time**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 Executive
5 months ago
Petaling Jaya, Malaysia Elanco Full timeEducation : 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...
-
Regulatory Affairs, Associate Manager
7 months ago
Petaling Jaya, Malaysia Johnson & Johnson Full time**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...
-
Regulatory Affairs Pharmaceutical
5 months ago
Petaling Jaya, Malaysia BioCare Pharmaceutical Sdn Bhd Full timeBiocare 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...
-
Regulatory Affairs Specialist
5 months ago
Petaling Jaya, Malaysia Biocare Pharmaceutical (M) Sdn Bhd Full time**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...
-
Regulatory Affairs Specialist
5 months ago
Petaling Jaya, Malaysia Materialise Full timeRegulatory 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...
-
International Regulatory Affairs Director
6 months ago
Petaling Jaya, Malaysia AstraZeneca Full time**_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...
-
Executive Regulatory Affairs
6 months ago
Petaling Jaya, Malaysia DKSH Full time**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...
-
Regulatory Affairs Specialist
6 months ago
Petaling Jaya, Malaysia Johnson & Johnson Full time**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...
-
Government Affairs and Tender Manager
7 months ago
Petaling Jaya, Malaysia IQVIA Full time**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...
-
Regulatory Affairs
6 months ago
Petaling Jaya, Malaysia Agensi Pekerjaan & Perundingcara Bright Prospect Sdn Bhd Full timeResponsible 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...
-
Regulatory Affairs Specialist
5 months ago
Petaling Jaya, Malaysia Philips Full time**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
5 months ago
Petaling Jaya, Malaysia FrieslandCampina Full timePublic 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...
-
Manager - External Affairs
6 months ago
Petaling Jaya, Malaysia Heineken Full time**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...
-
Regulatory Compliance Associate
5 months ago
Petaling Jaya, Malaysia allnex Full timeAt allnex, you can go to work knowing you make a lasting impact on the world. Our work helps to protect and improve more than 1,000 products: from interior coatings for airplanes, corrosion protection for cars, scratch-resistant coatings for smartphones to printing inks for glossy magazines at a newsstand. Sustainability is a commitment to our stakeholders...
-
Pharmacist, Operations Management
6 months ago
Petaling Jaya, Malaysia United Italian Trading (M) Sdn Bhd Full time**Positions**: a) Pharmacist b) Regulatory Affairs Manager c) Regulatory Affairs Assistant Manager d) Regulatory Affairs Senior Executive e) Regulatory Affairs Junior Executive **Responsibilities**: - Responsible for all regulatory affairs, regulatory compliance activities, and submission of pharmaceutical and medical device products of the Company. -...
-
Associate Regulatory Specialist
6 months ago
Petaling Jaya, Malaysia Ecolab International Full timeSupport 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...
-
Associate Market Access Manager
5 months ago
Petaling Jaya, Malaysia Johnson & Johnson Full time**Associate Market Access Manager** Location: Malaysia J&J Innovative Medicines Malaysia is currently looking for an Associate Market Access Manager to join our Market Access team. In this role, you will support and implement strategies and tactical plans in Malaysia. The primary objective of this role is to assist in improving patient access by enhancing...