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46 Regulatory Affairs Manager Jobs - August 2026 - Urgent Hiring
Showing 46 jobs results for
"regulatory affairs manager"
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Undisclosed
Singapore
- Oversee Clinical Trial Submissions: Coordinate and oversee the preparation of clinical trial applications across multiple regions, including the United States and Asia-Pacific. Ensure that all submissions are timely, complete, and meet relevant regulatory requirements. Support the preparation and submission of applications for regulatory designations (e.g., Fast Track, Breakthrough Therapy, Orphan Drug, etc.).
- Hands-On Implementation: Actively engage in the drafting, review, and coordination of regulatory documents, ensuring accuracy and timeliness. This role requires both strategic oversight and direct involvement in execution.
- Lifecycle Maintenance of Submissions: Manage post-submission activities including regulatory amendments, protocol and investigator brochure updates, and general IND/CTA maintenance across regions. ...
Posted
a day ago
Undisclosed
Singapore
- Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.
- Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, for the company to deliver products backed by science that are robust and aligned with business needs.
- Manage compliance within defined portfolio/activity streams in line with Haleon guidelines - support key processes and ways of working (e.g., in relation to Haleon CMC, quality, product labelling requirements as well as local MoH regulations). Propose solutions to identified issues and implement. ...
Posted
15 days ago
Undisclosed
Singapore
- at least 10 years experience within the financial services industry, with a focus on regulatory compliance, risk management or control frameworks
- Strong understanding of the Singapore regulatory environment, with awareness of broader APAC developments
- Experience in regulatory engagement, including dealing with regulatory enquiries or incidents ...
Posted
17 days ago
Undisclosed
- Assist in compiling and organizing documents required for product registration/information (e.g. MoH Food & Pharma. Div., RMCD, DOSH etc).
- Review and validate product labels, packaging, promotional materials, and technical documents from regulatory perspective to ensure regulatory compliance.
- Help translate or format technical documents when necessary. ...
Posted
22 days ago
Undisclosed
Singapore
- Submission Project Management
- Regulatory Operations & Publishing
- Quality & Compliance ...
Posted
23 days ago
Company Confidential
Undisclosed
Singapore
- Strong expertise in regulatory affairs, including experience developing and implementing Regulatory Affairs strategies and managing Regulatory Requirements.
- Proficiency in Regulatory Documentation, with a track record of preparing and reviewing technical files, clinical evidence, and supporting materials.
- Hands-on experience with Regulatory Submissions, including interacting with regulatory agencies and navigating approval processes. ...
Posted
a month ago
Undisclosed
KL City
- Leading the IRB modelling team in monitoring the credit models and scorecards performance and reporting them to management in a consistent and timely manner.
- Oversee the implementation of Basel credit models and scorecards into production systems, ensuring appropriate testing, validation and readiness prior to deployment.
- Lead the timely resolution of internal and independent model validation findings and ensure effective remediation plans are implemented. ...
Posted
3 days ago
Undisclosed
Singapore
- Provide advice on regulatory and competition policies, frameworks and requirements across telecoms, broadcast, personal data, digital infrastructure etc to business units and ensure that these are met and complied with.
- Key internal regulatory point of contact for business units, providing coordination and support across business units in order to analyse impact of regulatory policies and decisions, and prepare representation and submissions to IMDA and other government agencies to safeguard Singtel’s interests.
- Monitor, analyse upcoming policies, regulations, laws, guidelines in Singapore and proactively review and advise the impact and implications across all the business units, and support in business units’ response plans. ...
Posted
11 days ago
Undisclosed
Malaysia
- We continuously innovate to transform our financial services landscape - making banking better and easier. Join us at AFFIN, where the open minds meet and be inspired by a shared commitment to great work. You too can make a difference.
- JOB PURPOSE
- This role is responsible for leading the Bank's Basel III Credit Risk Internal Ratings-Based (IRB) implementation project, including the development of Basel credit model development, project management, governance, and organisational change management. The role ensures successful implementation of the Basel III Capital Adequacy Framework (CAF) Credit Risk requirements in compliance with Bank Negara Malaysia (BNM) regulations while driving the development, implementation and ongoing governance of Basel credit risk models across the Bank. ...
Posted
15 days ago
Undisclosed
- Supporting the Pharma commercial teams on topics including regulatory, legal compliance, quality and product safety.
- Document preparation, handling product registration applications ensuring drugs are legally authorised for the markets intended.
- Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA’s & TA’s). ...
Posted
3 days ago
Equitable Technologies
Undisclosed
KL City
- Develop and lead the regulatory strategy for U.S. FDA (510(k) or De Novo), CE-marking, and Malaysian MDA approvals.
- Map out regulatory pathways for a novel ingestible diagnostic device (hardware + software + data).
- Identify predicate devices or justify De Novo submission (if needed). ...
Posted
a month ago
Undisclosed
Singapore
- Conduct post-market compliance check to ensure the continued safety of marketed complementary health products and cosmetic products, including recommendations and follow-up on regulatory actions to ensure the safe and appropriate use of these products.
- Manage enquiries and feedback from industry stakeholders and members of public, track key performance indicators through dashboards, and analyse data to provide insights on enquiries or identify trends and areas for service improvement.
- Develop digital resources such as video guides, e-learning materials, and step-by-step visual guides to support indsutry engagement and to guide industry stakeholders compliance with regulatory requirements ...
Posted
3 days ago
JUST RECRUIT SINGAPORE PTE. LTD.
SGD10,000 - SGD10,000 Per Month
Singapore
- Regulatory Tracking & Submissions: Monitor regulatory developments relevant to Anchor, maintain regulatory obligations register and coordinate timely preparation and submission of required regulatory deliverables and responses.
- Compliance Liaison: Act as the interface between the program team and Compliance/Legal functions ensuring all workstream activities adhere to applicable regulations, internal policies, and audit requirements.
- Regulatory Reporting: Produce accurate and timely regulatory packs, track open regulatory actions to closure, and support preparation for regulatory examinations or reviews. ...
Posted
21 days ago
Undisclosed
Singapore
- Own APAC regulatory strategy and ensure compliance across relevant sectors (food & nutrition plus select non-food categories).
- Enable commercialization: guide claims, labels, and marketing communications with science-based, compliant positions.
- Lead approvals/registrations where required to support market access across APAC. ...
Posted
19 days ago
Undisclosed
Singapore
- Define and execute regulatory strategies for new and existing products, ensuring timely market authorizations, license maintenance, and compliance with country‑specific requirements across Asia Pacific markets.
- Manage and maintain the Quality Management System, including documentation control, SOP creation and revision, quality metrics monitoring, and compliance with GMP, GDP and ISO standards.
- Lead lot release and batch inspection processes, overseeing qualified third‑party logistics providers, external warehouses, and ongoing compliance through periodic follow‑ups and quality audits. ...
Posted
22 days ago
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