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100+ Regulatory Affairs Jobs - October 2026 - Urgent Hiring
Showing 190 jobs results for
"regulatory affairs"
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Manage Alert
Undisclosed
- Monitor and assess policies, regulations and government initiatives affecting the data center industry; advise management on regulatory implications, risks and opportunities; and develop policy positions and regulatory strategies.
- Build and maintain strategic relationships with Federal and State Governments, ministries, agencies, regulators and government-linked entities; lead government engagement and facilitate government support for data center projects.
- Support Solutions, Operations and other internal stakeholders in leading authority engagement and permitting activities throughout the project lifecycle; identify required approvals, licences and permits; coordinate submissions; and drive resolution of authority requirements and approval conditions. ...
Posted
8 days ago
Undisclosed
Singapore
- Communicating clearly with regulators and the business, including breaking down complex information into smaller, digestible chunks
- Keeping our regulators up to date with new products, initiatives, and other ad hoc updates
- Working with the wider Risk and Compliance team to share communications during an incident ...
Posted
18 days ago
Undisclosed
Singapore
- Regulatory Strategy & Portfolio Leadership
- Develop and execute regulatory strategies across the product lifecycle, including new registrations, indications, renewals, variations, and post-approval changes.
- Ensure regulatory strategies support business objectives, patient access, and portfolio expansion. ...
Posted
12 days ago
Undisclosed
Singapore
- Orion Group Life Sciences are currently recruiting a Regulatory Affairs Manager on behalf of our Multinational Biopharmaceutical Client based in North Buona Vista Drive, Singapore on an initial 12-month contract with potential to extend.
- The Manager, Regulatory Affairs (RA) serves as the primary JAPAC representative of the regulatory affairs function within both the R&D and commercial organizations for all matters related to assigned therapeutic areas and products. The incumbent is responsible for defining, implementing, and delivering Area and Affiliate regulatory strategies across a portfolio of compounds in late-stage development and marketed products within the JAPAC region. With knowledge in regional regulatory requirements, the role acts as a subject matter expert for assigned countries, continuously monitoring and interpreting regulatory policy and intelligence relevant to those markets. In addition, the incumbent represents the RA function in cross-functional initiatives being led out of the Area office.
- Major Responsibilities: ...
Posted
19 days ago
Undisclosed
- Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
- Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
- Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements. ...
Posted
13 days ago
Undisclosed
- Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
- Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
- Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements. ...
Posted
14 days ago
ONE STOP ENGINEERING PTE. LTD.
SGD8,000 - SGD15,800 Per Month
Singapore
- Lead and execute regional Regulatory Affairs (RA) initiatives for JAPAC in partnership with global, area, and affiliate teams; ensure timely project completion and efficient communication and implementation of plans.
- Serve as the primary RA liaison to affiliate teams for assigned programs, maintaining clear and productive communication channels.
- Serve as primary RA point of contact with local health authorities (through affiliate RA personnel); prepare teams for agency consultations by aligning briefing materials with the regulatory strategy, and ensure outcomes are communicated promptly to stakeholders. ...
Posted
12 hours ago
MYR3,000 - MYR5,000 Per Month
- Ensure products comply with regulatory requirements for assigned export markets.
- Review and interpret country-specific food regulations, import requirements and market entry requirements.
- Assess product formulations, ingredients, food additives, processing aids, packaging materials, nutrition information and product claims against applicable regulations. ...
Posted
8 hours ago
Undisclosed
Singapore
- Lead US IND strategy with direct FDA engagement
- High-impact role ahead of global trial in 2027
- Lead the design and execution of global regulatory strategies across pipeline assets ...
Posted
5 days ago
Undisclosed
- Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada under supervision. Responsible for ensuring the files are in compliance with relevant regulations and standards.
- Assist in regulatory submissions, license applications and amendments (e.g., 510(k), EU MDR, Health Canada) by compiling documents and performing administrative tasks.
- Support the organization in change control activities/ product development for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate. ...
Posted
6 days ago
RANDSTAD PTE. LIMITED
SGD4,000 - SGD4,000 Per Month
Singapore
- Prepares submission dossiers for post-approval variations within agreed timelines.
- Maintains general knowledge of latest regulatory requirements.
- Establish and maintain good working relationships with internal and external stakeholders. ...
Posted
7 days ago
ZOLL Medical Corporation
Undisclosed
- Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
- Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
- Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups ...
Posted
11 days ago
Undisclosed
Singapore
- Generate regulatory strategies
- Liaise with colleagues globally
- Review submission packages ...
Posted
18 days ago
Undisclosed
KL City
- Establish and execute a regulatory monitoring strategy to stay ahead of updates in Malaysian laws, SIRIM/DOSH/MDTCA standards, and technical regulations.
- Translate complex regulatory updates into practical, actionable guidance for business and product teams.
- Organize internal compliance committees and participate in external technical committees or public affairs discussions. ...
Posted
13 days ago
Regulatory Affairs and Business Development Executive Regulatory Affairs and Business Development Executive
Teh Lin Prosthetic & Orthopaedic Centre
MYR3,500 - MYR4,500 Per Month
KL City
- Prepare and submit regulatory documents for prosthetic and orthotic products to relevant regulatory authorities.
- Manage and monitor product registration, approval and regulatory submission processes to ensure timely completion.
- Maintain up-to-date knowledge of applicable regulations, including MDA, GDPMD, MDR, ISO 13485 and other relevant medical device requirements. ...
Posted
13 days ago
Undisclosed
KL City
- This role offers the opportunity to work closely with Boehringer Ingelheim teams on meaningful operational initiatives in a fast-paced environment. Please note that this is an agency-hired assignment, and all employment terms and conditions will be managed the agency .
Posted
20 days ago
Undisclosed
Singapore
- Serves as the primary JAPAC representative of the regulatory affairs function within both the R&D and commercial organizations for all matters related to assigned therapeutic areas and products.
- Responsible for defining, implementing, and delivering Area and Affiliate regulatory strategies across a portfolio of compounds in late-stage development and marketed products within the JAPAC region.
- Acts as a subject matter expert for assigned countries, continuously monitoring and interpreting regulatory policy and intelligence relevant to those markets. ...
Posted
a day ago
Undisclosed
- Strong foundation in Regulatory Affairs, with experience in medical device regulations and registration processes.
- Proficiency in Regulatory Documentation and Dossier Preparation, including creating, organizing, and updating technical files and submission packages.
- Knowledge of Regulatory Requirements and Regulatory Compliance, including awareness of relevant Malaysian and international standards and guidelines. ...
Posted
15 days ago
Undisclosed
- Responsible for local regulatory submissions, developing regulatory strategies, and ensuring compliance with applicable laws and regulations.
- Collaborate with various internal departments and external agencies to achieve regulatory objectives and support business goals.
- Stay up to date with regulatory changes and maintain positive relationships with regulatory authorities and trade associations. ...
Posted
25 days ago
Undisclosed
KL City
- Partner with R&D and cross-functional project teams to provide regulatory and standards compliance advice throughout product development.
- Define regulatory pathways and documentation requirements for new products and software releases.
- Support the development of regulatory strategies that align with business objectives and global market access plans. ...
Posted
25 days ago
Undisclosed
- Develop and maintain strong relationships with internal regulatory teams, affiliates, and distributors to ensure effective stakeholder management and operational excellence.
- Collaborate with affiliates and distributors to assess the impact of regulatory changes and ensure appropriate follow-up actions are implemented.
- Drive continuous improvement initiatives and optimize regulatory tools, systems, and ways of working. ...
Posted
6 days ago
Undisclosed
- Administer regulatory document control systems, ensuring controlled versioning, traceability, and document integrity.
- Manage regulatory correspondence, authority notices, approvals, conditions, and statutory communications.
- Maintain structured regulatory registers, licence matrices, approval logs, and authority engagement records. ...
Posted
25 days ago
Undisclosed
- Plan and deliver assigned product LCM activities in line with market plans, agreed priorities, internal objectives, local requirements and applicable global procedures.
- Prepare, compile and customise submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents and supporting records.
- Coordinate CMC and non-CMC content with International iRAMs, iRADs and iCMC; identify package gaps and secure timely, approved source documents and responses. ...
Posted
7 days ago
Undisclosed
- Lead the CoE assigned LCM portfolio and delivery scorecard in alignment with regional and MC business priorities, agreed service levels and compliance expectations.
- Own demand intake, prioritisation, work allocation, capacity visibility and delivery governance for LCM activities transferred from participating MC teams.
- Lead complex or high-impact dossier customisation and submission delivery, providing expert advice on country requirements, post-approval pathways, CMC change management and operational strategy. ...
Posted
7 days ago
SGD5,500 - SGD5,500 Per Month
Singapore
- Plans regulatory strategy and supports New Drugs Application (NDA) and supplemental submissions within agreed timelines
- Perform regulatory assessments and prepare submission dossiers for variations
- Timely communication with Regional/Global RA on regulatory strategies, submissions and approvals ...
Posted
7 days ago
Undisclosed
- Plan and deliver assigned product LCM activities in line with market plans, agreed priorities, internal objectives, local requirements and applicable global procedures.
- Prepare, compile and customise submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents and supporting records.
- Coordinate CMC and non-CMC content with International iRAMs, iRADs and iCMC; identify package gaps and secure timely, approved source documents and responses. ...
Posted
7 days ago
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