Regulatory Manager, APAC
3 days ago
The primary role of the
REGULATORY MANAGER, ASIA PACIFIC
is to oversee the product registrations and regulatory pathways in Asia Pacific. He/she needs to ensure compliance with Asia Pacific regulations.
In this role, you will influence key decision-making processes with ample opportunities for enterprise-wide impact, exposure, learning, and development.
Key Responsibilities:
Regulatory strategy and submission for Oncology, Nutrition, and CNS products in Asia Pacific
Independently manages and executes all aspects for the successful preparation, submission, and timely approval of applications, variations, post-approval reporting obligations, and general product life cycle management of assigned program.
Develop, implement, and maintain regulatory strategies for the products in line with the Company's global objectives and local requirements.
Prepare, review, and submit regulatory dossiers to the Asia Pacific regulatory bodies.
Effectively communicates the regulatory strategies, submission plans, and timelines; impact assessment of trends, regulations, and changes related to the assigned programs.
Manage the regulatory submission process, including timely preparation of submission documents and ensuring submission within project/commercial launch timelines.
Regulatory compliance
Ensuring compliance with Asia Pacific regulatory bodies.
Monitor regulatory changes and emerging trends in the space where the Company operates. Also provide guidance to the internal stakeholders on the changes/impact.
Provide regulatory input into the development and marketing of the products, not limiting to clinical trial design, labeling, and promotional material review.
Liaison with Regulatory Authorities
Act as the primary point of contact with regulatory authorities.
Prepare and participate in meetings with regulatory agencies, including answering queries, addressing requests for additional information, and negotiating approvals.
Maintain productive relationships with regulatory bodies to facilitate efficient approval processes.
Cross-functional Collaboration
Work closely with internal teams (clinical, medical affairs, manufacturing, quality assurance, and marketing) to ensure alignment on regulatory strategy and project timelines.
Provide regulatory input to support clinical trials, product development, and post-market activities.
Support the preparation of regulatory documentation for product lifecycle management, including changes to product labeling, packaging, and marketing authorizations.
Requirements:
A degree in life sciences, pharmacy, or a related field preferred.
Minimum 8 years of regulatory affairs experience in the healthcare industry in Asia Pacific.
Experience with oncology clinical trials and regulatory requirements for investigational new drugs.
Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in development and life cycle management.
Excellent communication and negotiation skills, both written and verbal, with the ability to engage effectively with regulatory agencies, cross-functional teams, and senior leadership.
Strong problem-solving skills and the ability to navigate complex regulatory environments.
Demonstrated ability to manage multiple projects simultaneously, with a high degree of organization and attention to detail.
Ability to work independently and as part of a collaborative team in a fast-paced environment.
#J-18808-Ljbffr
-
Regulatory Reporting Lead APAC
7 days ago
Singapore Taylor Root Full timeAbout the RoleWe are seeking a seasoned regulatory reporting professional to join our team in Singapore. As a Regulatory Reporting Lead APAC, you will be responsible for driving compliance initiatives, managing regulatory filings, and collaborating with key stakeholders across the business.The successful candidate will have a strong understanding of APAC...
-
APAC Regulatory Reporting Specialist
7 days ago
Singapore Taylor Root Full timeAbout the CompanyTaylor Root is a leading international recruitment firm partnering with top financial institutions to hire the best talent. We are currently working with a renowned bank to find a skilled APAC Regulatory Reporting Specialist to join their dynamic team in Singapore.This is a newly created role for an experienced regulatory reporting...
-
Regulatory Affairs Specialist APAC
7 days ago
Singapore Wise Full timeJob DescriptionThis role offers an exciting opportunity to join Wise's APAC team as a Product Compliance & Risk Manager. The successful candidate will be responsible for ensuring compliance with regulatory requirements and managing financial crime risks across various markets and integrations globally.The ideal candidate will have expertise in regulatory and...
-
APAC Brand Manager
7 days ago
Singapore Midea APAC Full timeThe APAC Brand Manager will oversee the development and execution of brand communication strategies across multiple markets in the APAC region.This role involves working closely with internal teams and external partners to enhance brand visibility, drive consumer engagement, and ensure consistency across marketing channels.Key responsibilities...
-
APAC Project Planning Manager
7 days ago
Singapore Midea APAC Full timeJob DescriptionMidea APAC is looking for a talented APAC Project Planning Manager to oversee regional operations and ensure successful project outcomes. Key responsibilities include strategic planning, project coordination, and team leadership.Main Tasks• Develop and implement project plans aligned with business objectives;• Manage project schedules,...
-
APAC Business Development Lead
7 days ago
Singapore Midea APAC Full timeAPAC Business Development Lead: A Key Role in Midea's Success We are looking for an experienced APAC Business Development Lead to join our team. In this critical role, you will be responsible for identifying and pursuing new business opportunities across the APAC region.About the TeamOur sales and business development team is dedicated to driving growth and...
-
Senior Project Executive APAC
7 days ago
Singapore Midea APAC Full timeJob OverviewMidea APAC seeks a skilled Senior Project Executive APAC to lead cross-functional strategic project planning and execution for the APAC Region. This role ensures key projects, timelines, and deliverables are aligned with business objectives.Main Responsibilities• Plan and execute complex projects across the APAC Region;• Monitor project...
-
Regulatory Affairs Director, APAC
3 weeks ago
SG, SINGAPORE, VIRTUAL Solventum Full timeThank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...
-
Regional Business Growth Manager, APAC
7 days ago
Singapore Midea APAC Full timeJob SummaryWe are seeking a results-driven Business Development Executive to identify and develop new business opportunities in the Asia Pacific region. The ideal candidate will have strong sales and negotiation skills, a deep understanding of market trends, and the ability to drive business growth.The successful candidate will be responsible for building...
-
Information Security Consultant
2 weeks ago
Singapore ARGYLL SCOTT CONSULTING PTE. LTD. Full timeRoles & ResponsibilitiesWe are looking for a GIS APAC Regulatory Exam Management Consultant on a 12 months contract basis to start with a potential to extend further. What you can expect: The Global Information Security Risk, Regulatory Policy team in Asia Pacific provides oversight for holistic alignment across laws, rules, and regulations (LRRs),...
-
Singapore Taylor Root Full timeAbout the OpportunityWe are excited to offer a unique opportunity for a skilled Compliance Manager Regulatory Reporting Singapore to join our client's team in Singapore. This is a newly created role for an experienced regulatory reporting professional to drive compliance initiatives, manage regulatory filings, and collaborate with key stakeholders across the...
-
Regulatory Manager, APAC
3 days ago
Singapore Private Advertiser Full timeThe primary role of the REGULATORY MANAGER, ASIA PACIFIC is to oversee the product registrations and regulatory pathways in Asia Pacific. He/she needs to ensure compliance with Asia Pacific regulations. In this role, you will influence key decision-making processes with ample opportunities for enterprise-wide impact, exposure, learning, and development. Key...
-
Sales Performance Manager
7 days ago
Singapore Midea APAC Full timeMidea APAC: Driving Sales Growth in the APAC Region As a Sales Performance Manager at Midea APAC, you will play a crucial role in driving sales growth and optimizing channel performance in the home appliances industry across the APAC region. Your primary responsibility will be to develop and maintain strong relationships with channel partners.About the...
-
Regulatory Compliance Expert
7 days ago
Singapore Barclays Full timeThis is an exciting opportunity at Barclays to take on a key role as part of APAC Operations, where you will be responsible for regulatory adherence to regulations. Your focus will be on ensuring the completeness, accuracy, and timeliness of regulatory reporting.You will be the primary contact point for Compliance, Business, and Regulatory Relations, working...
-
Financial Business Partner
3 days ago
Singapore APAC Michael Page Full time**Job Summary**We are seeking an experienced Financial Business Partner to join our APAC team. As a key member of our finance function, you will be responsible for managing full-set accounts, preparing and reviewing monthly financial reports, and driving budgeting and forecasting processes.You will also oversee GST and corporate tax submissions, lead...
-
APAC Quality Manager
7 days ago
Singapore Alcon Full timeAbout the RoleWe are seeking a highly motivated and experienced quality professional to join our team as an APAC Quality Manager. The successful candidate will be responsible for leading the development, implementation, and maintenance of quality systems across APAC affiliates and distribution locations. This is a key role that requires strong leadership,...
-
Regulatory Affairs Manager
2 weeks ago
Singapore BRUNEL INTERNATIONAL SOUTH EAST ASIA PTE. LTD. Full timeRoles & ResponsibilitiesOur client is a global pharmaceutical company with a wide product portfolioDevelop and implement regulatory strategies for new and existing products in the assigned regions. Provide guidance to the company regarding regulatory requirements and ensure compliance with all relevant regulations. Submission and coordination with H.S.A....
-
Regional Personal Lines Actuary, APAC
2 weeks ago
Singapore AIG APAC HOLDINGS PTE. LTD. Full timeRoles & ResponsibilitiesAt AIG, we are reimagining the way we help customers to manage risk. Join us as a Regional Personal Lines Actuary, APAC to play your part in that transformation. It’s an opportunity to grow your skills and experience as a valued member of the team.Make your mark in ActuarialOur Actuaries are on the front lines, quantifying risk,...
-
Regional Personal Lines Actuary, APAC
2 weeks ago
Singapore AIG APAC HOLDINGS PTE. LTD. Full timeRoles & ResponsibilitiesAt AIG, we are reimagining the way we help customers to manage risk. Join us as a Regional Personal Lines Actuary, APAC to play your part in that transformation. It's an opportunity to grow your skills and experience as a valued member of the team.Make your mark in ActuarialOur Actuaries are on the front lines, quantifying risk,...
-
Project Manager, Regulatory Affairs
2 weeks ago
Singapore ASIA PACIFIC MEDICAL TECHNOLOGY ASSOCIATION LTD. Full timeRoles & 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...