Manager, Regulatory Affairs

2 months ago


Singapur, Singapore Thermo Fisher Scientific Full time
:

Lead SEA Q&RA team, develop the current talents and ensure sufficient resource to support the business growth. Implement effective regulatory and quality policy.

Regulatory Partner to SEA collaborators - Commercial, Division Leaders, Channel Partners Operations and Distributors. Lead pre-market registrations to support business expansion and new product introduction in line with Group’s and Division’s strategies. Collaborate with distributors, coordinating their performance to ensure there is no disruption to the marketed products, improve the process where necessary.

Collaborate with Global Divisions on prioritization of projects, regulatory plan, propose measurable inputs to achieve the earliest possible approvals for go-to-market.

Coordinate and provide regulatory assessment to market responses and needs during product lifecycle management, ensure change will not impact the product in the market.

Become an Expert in regulatory landscape and intelligence, communicate with clarity, evaluate the impact and provide the required actions to meet the latest Medical Device and IVD regulations.

Building advocacy and rapport with Regulatory Authorities, actively engage and represent Thermo Fisher in regional and local trade association.

Implement global post market surveillance, field safety notifications, recalls according to local reporting requirements.

Evaluate the labeling and promotional materials meeting local regulatory requirements.

Singapore Management Representative of Thermo Fisher Microbiology ensuring Goods Distribution Practice (GDPMDS) requirements and certification.



  • Singapur, Singapore BeiGene Full time

    Job Description: About the Position The Senior Regulatory Affairs Associate / Regulatory Affairs Manager is responsible for ensuring the regulatory compliance of therapeutic products in Singapore and other South East Asia (SEA) developing and executing regulatory strategic plans and supporting product registration and managing product life cycle...


  • Singapur, Singapore IQVIA Full time

    Responsibilities: Assist the Head of Regulatory services in assuming primary or secondary regulatory responsibility for assigned projects by providing the project team with regulatory information, guidance, training, support and strategic planning based on applicable regulations issued by the regulatory agencies across JAPAC. Deliver on regulatory...


  • Singapur, Singapore Boston Scientific Full time

    Summary Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team...


  • Singapur, Singapore 812 GlaxoSmithKline Pte Limited Full time

    Purpose The Regulatory Affairs Manager is required to support the business primarily in Singapore by leading the portfolio life cycle management, driving new registration filings and line extensions, managing regulatory activities and labelling updates for the products in the defined therapeutic areas in GSK. The Manager is also required to manage...


  • Singapur, Singapore Gilead Sciences Singapore Pte. Ltd. Full time

    Description   Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s...


  • Singapur, Singapore Boston Scientific Full time

    Summary Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation.  Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any questions on product documentation.  Provide management team...


  • Singapur, Singapore Gilead Sciences Full time

    Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s...


  • Singapur, Singapore Abbott Full time

    The Opportunity This Associate Director Regulatory Affairs – APAC will work on-site at our Alameda, CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed,...


  • Singapur, Singapore Boston Scientific Full time

     Additional Locations: Australia-NSW-Mascot; China-Shanghai; Japan-Tokyo Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important...


  • Singapur, Singapore Abbott Full time

    The Opportunity As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory...


  • Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Singapur, Singapore Baxter Full time

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Singapur, Singapore Boston Scientific Full time

     Additional Locations: Australia-NSW-Mascot; China-Shanghai; Japan-Tokyo Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important...


  • Singapur, Singapore Cepheid Full time

    Specific duties include but are not limited to: Lead and manage a team of regulatory and quality professionals, fostering a culture of excellence, collaboration, and continuous improvement including: creating regulatory strategies, preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to...


  • Singapur, Singapore Sephora Full time

    At Sephora we inspire our customers, empower our teams, and help them become the best versions of themselves.  We create an environment where people are valued, and differences are celebrated. Every day, our teams across the world bring to life our purpose: to expand the way the world sees beauty by empowering the ExtraOrdinary in each of us. We are united...


  • Singapur, Singapore 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: We are looking for a talented, experienced, and motivated...


  • Singapur, Singapore Edelman Full time

    The business affairs role will partner with the Brand, Creative, Production, Influencer, and other teams in the business to manage projects with minimal oversight. We are looking to bring a new team member on board for this role as Business Affairs global footprint has been steadily increasing – and there is now the need for a dedicated business affairs...


  • Singapur, Singapore AstraZeneca Full time

    About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. Our team plays a crucial role in making...


  • Singapur, Singapore Cisco Full time

    What You’ll Do Cisco is looking for a government affairs professional to join our global team as the Head of Government Affairs in ASEAN. Reporting to the Senior Vice President of International Government Affairs, you will lead Cisco’s government engagements and public policy efforts throughout ASEAN. Your key responsibilities will include: ...


  • Singapur, Singapore CorDx Full time

    Job Responsibilities Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization). Be the subject matter expert on medical devices laws and regulations for product registration in company’s regions of interest. Interface the...