Regional regulatory affairs manager

3 weeks ago

Singapore Abbott Laboratories Full time

Regional Regulatory Affairs Manager Apply locations Singapore time type Full time posted on Posted 2 Days Ago job requisition id 31105192 JOB DESCRIPTION: At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. Job Purpose: Manages teams within the Regulatory Affairs Sub-Function. Focus is on policy and strategy implementation and control rather than development. Typically handles short-term operational/tactical responsibilities. Responsibilities As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle. Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, local submission package/chemistry manufacturing control (CMC) preparation. Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products. Serves as regulatory representative to marketing, research teams and regulatory agencies. Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Requirements A bachelor's degree in a related field Min 7 years of experience Preferably in the pharmaceutical and/or Health or medical device industry. Knowledge & experience in diabetes will be advantageous. An excellent communicator, both verbally & in writing. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: ADC Diabetes Care LOCATION: Singapore Singapore : DUO Tower ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable About Us Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. #J-18808-Ljbffr

  • Regional Regulatory Affairs Executive

    3 weeks ago

    Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full time

    Roles & ResponsibilitiesPOSITION SUMMARY:The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.KEY RESPONSIBILITIES: Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater...

  • Regional Regulatory Affairs Executive

    4 weeks ago

    Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full time

    Roles & ResponsibilitiesPOSITION SUMMARY:The Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.KEY RESPONSIBILITIES: Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater...

  • Project manager, regulatory affairs

    1 month ago

    Singapore PRESTIGE BIOPHARMA LTD Full time

    JOB FUNCTION Project Manager, Regulatory Affairs MAIN RESPONSIBILITIES Manage project submissions as assigned by Regulatory Affairs leadership Support the management of key projects, including execution, for submission, approval, and launch Review, prepare and author documents for regulatory submissions including clinical trial applications, marketing...

  • Regional Regulatory Affairs Manager

    4 weeks ago

    Singapore Abbott Laboratories Full time

    At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose...

  • Regional regulatory affairs specialist

    4 weeks ago

    Singapore Ambition Group Singapore Pte. Ltd. Full time

    We are working with a fast-growing Asian based medical devices company, and they are expanding rapidly across the region. Due to their growth, they are looking to expand the RA function to support the RA Director in any applicable regulatory and quality requirements. Responsibilities Reporting to the Regional Regulatory Affairs Director, you will play an...

  • Regional Regulatory affairs Director, Asia Pacific

    4 weeks ago

    Singapore SL-Human Resource Consultancy Pte Ltd Full time

    Job Title: Regulatory Affairs Director Location:  Singapore Department: Regulatory Affairs Reports to: Vice President of Regulatory Affairs Position Summary: Our client is seeking an experienced and strategic Regulatory Affairs Director to join the team in Singapore. The Regulatory Affairs Director will be responsible for overseeing and managing all...

  • Regulatory affairs specialist

    3 weeks ago

    Singapore PSA International Full time

    Job Title: Regulatory Affairs Specialist The company is a fast-growing food and beverages business with a strong presence across Asia. Key Responsibilities: Develop and implement regulatory strategies to ensure compliance with all applicable laws and regulations. Stay up-to-date on changes in regulatory requirements and translate them into actionable steps...

  • Senior Specialist, Regulatory Affairs

    2 weeks ago

    Singapore INTERNATIONAL FLAVORS & FRAGRANCES (GREATER ASIA) PTE. LTD. Full time

    Roles & ResponsibilitiesJob SummaryThis position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other...

  • Senior Specialist, Regulatory Affairs

    1 month ago

    Singapore INTERNATIONAL FLAVORS & FRAGRANCES (GREATER ASIA) PTE. LTD. Full time

    Roles & ResponsibilitiesJob SummaryThis position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other...

  • Associate, Regulatory Affairs

    2 months ago

    Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    Roles & ResponsibilitiesAbout APACMedFounded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional MedTech association in APAC, representing medical technology manufacturers (multinational corporations as well as small and medium enterprises), and local industry associations across the region. We are fully...

  • Project Manager, Regulatory Affairs

    18 hours ago

    Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    Roles & ResponsibilitiesOverviewThe Project Manager, Regulatory Affairs, plays a pivotal role in driving APACMed's Regulatory Affairs (RA) agenda across the Asia-Pacific region. The position involves managing complex RA initiatives, fostering collaboration among stakeholders, and ensuring the successful delivery of high-impact projects aligned with the...

  • Project Manager, Regulatory Affairs

    16 hours ago

    Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full time

    Roles & ResponsibilitiesOverviewThe Project Manager, Regulatory Affairs, plays a pivotal role in driving APACMed's Regulatory Affairs (RA) agenda across the Asia-Pacific region. The position involves managing complex RA initiatives, fostering collaboration among stakeholders, and ensuring the successful delivery of high-impact projects aligned with the...

  • Project Manager, Regulatory Affairs

    3 weeks ago

    Singapore PRESTIGE BIOPHARMA LIMITED Full time

    Roles & ResponsibilitiesJOB FUNCTIONProject Manager, Regulatory AffairsMAIN RESPONSIBILITIES· Manage project submissions as assigned by Regulatory Affairs leadership· Support the management of key projects, including execution, for submission, approval, and launch· Review, prepare and author documents for regulatory submissions including clinical trial...

  • Project Manager, Regulatory Affairs

    4 months ago

    Singapore PRESTIGE BIOPHARMA LIMITED Full time

    Roles & ResponsibilitiesJOB FUNCTIONProject Manager, Regulatory AffairsMAIN RESPONSIBILITIES· Manage project submissions as assigned by Regulatory Affairs leadership· Support the management of key projects, including execution, for submission, approval, and launch· Review, prepare and author documents for regulatory submissions including clinical trial...

  • Regulatory affairs lead

    3 days ago

    Singapore Novo Nordisk AS Full time

    Category: Reg Affairs & Safety Pharmacovigilance Location: Singapore, Singapore, SG Are you passionate about regulatory strategies? Do you want to make a significant impact in the APAC region? Are you ready to lead and support our affiliates while representing the region in global settings? We are looking for a dedicated Regulatory Affairs Lead to join our...

  • Regulatory affairs coordinator

    2 months ago

    Singapore ResMed Inc Full time

    Regulatory Affairs Coordinator Location: Singapore, Singapore Time Type: Full time Posted on: 5 Days Ago Job Requisition ID: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of...

  • Regulatory affairs coordinator

    2 months ago

    Singapore ResMed Inc Full time

    Regulatory Affairs Coordinator Apply to locations: Singapore, Singapore Time type: Full time Posted on: 6 Days Ago Job requisition id: JR_035534 The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the...

  • Senior regulatory affairs specialist

    1 month ago

    Singapore Airswift Full time

    Senior Regulatory Affairs Specialist (1-Year Contract) Location: Singapore (On-Site) We are seeking a Senior Regulatory Affairs Specialist to join a dynamic global healthcare organization specializing in innovative diagnostic solutions. This role focuses on regulatory submissions and license management across high-growth markets in the Asia-Pacific region....

  • Asia Pacific Regulatory Affairs Director

    4 weeks ago

    Singapore A. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. Full time

    Job DescriptionA. MENARINI ASIA-PACIFIC HOLDINGS PTE. LTD. is seeking a highly skilled Regional Regulatory Affairs Executive to lead our team in Asia Pacific.About the RoleThe successful candidate will be responsible for managing the registration submissions and lifecycle of pharmaceutical products in APAC regions, including ASEAN, Greater China, Hong Kong &...

  • Regulatory Affairs Lead

    2 weeks ago

    Singapore Novo Nordisk Full time

    Are you passionate about regulatory strategies? Do you want to make a significant impact in the APAC region? Are you ready to lead and support our affiliates while representing the region in global settings? We are looking for a dedicated Regulatory Affairs Lead to join our team. Read more and apply today for a life-changing career.Headquartered in...