BD (Becton, Dickinson and Company) Regulatory Affairs Manager in Kuala Lumpur, Malaysia
Job Description Summary
• Reporting into the Senior Manager, Regulatory Affairs, South East Asia, this role will lead the Regulatory Affairs function for BD Singapore, Malaysia and Pakistan to meet and support strategic business objectives. This role includes leading a team of Regulatory Affairs associates.
• Ensure that products relevant to the businesses are registered and submitted on time to support strategic business objectives
• Accountable and responsible for all pre-market, on-market and post-market regulatory activities
• Partner with Businesses and Functions to align regulatory strategies with those of Businesses and Functions
• Maintain country oversight of the changing regulatory environment
• Develop relationships with government agencies, regulatory agencies and relevant trade associations
• Lead regulatory intelligence and advocacy efforts with government agencies, regulatory agencies and relevant trade associations
• Collaborate and support country GM, regional and local business leaders and regional RA leaders in the region in regulatory intelligence and advocacy efforts
(1) Lead and direct the Regulatory Affairs function
(2) Partner with Businesses and Functions to align regulatory strategies with those of Businesses and Functions
(3) Serve as a key member in SEA RA team, interacting regularly with the Businesses and Functions to support and achieve business objectives. Align with Country GM and country business on the relevant products to register and to ensure the timely registration of these products.
(4) Accountable and responsible for all pre-market, on-market and post-market regulatory activities. These includes but not limited to:
Management of the preparation of regulatory submissions for marketing authorization applications to the regulatory authorities
Management of the maintenance of necessary regulatory records.
Approval of promotional materials
Provision of local regulatory expertise to regional and global stakeholders as required.
Undertake project work as requested by Country GM, Head of SEA RA, and Regional Head of Regulatory Affairs, Greater Asia
(5) Maintain country oversight of the changing regulatory environment. This includes but not limited to:
Develop relationships with government agencies, regulatory agencies and relevant trade associations
Lead regulatory intelligence and advocacy efforts with government agencies, regulatory agencies and relevant trade associations
Collaborate and support country GMs, regional and local business leaders and RA leaders in the region in regulatory intelligence and advocacy efforts
(6) Coach and develop RA associates to upscale and upgrade regulatory skill sets
(7) Work with SEA Region, Greater Asia Region and International Regulatory Affairs on the development of regulatory processes and practices to ensure operational effectiveness and efficiency.
Primary Work Location
MYS Kuala Lumpur - Damansara Heights
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.