CrawlJobs Logo

Senior Regulatory Affairs Specialist – Regional

https://www.baxter.com/ Logo

Baxter

Location Icon

Location:
Malaysia , Petaling Jaya

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

This role offers an exciting opportunity to provide regional regulatory support for new product development and post‑market activities within Baxter’s medical device portfolio. You will be hands‑on in shaping regulatory strategies, ensuring smooth product registrations, and keeping pace with evolving requirements. From new registrations and renewals to post‑approval changes and stakeholder engagement, you’ll play a critical role in enabling Baxter’s innovations to reach patients safely and compliantly across the region.

Job Responsibility:

  • Develop and execute regulatory project plans that keep products moving efficiently through approval pathways
  • Identify and escalate regulatory risks early, ensuring proactive solutions
  • Stay ahead of evolving regulations and translate requirements into clear, actionable steps
  • Maintain accurate and compliant regulatory files and documentation
  • Actively contribute to project teams, offering practical regulatory guidance
  • Respond to inquiries from regulatory authorities within strict timelines
  • Compile, prepare, and submit new registrations, variations, renewals, and change notifications to secure timely approvals
  • Review and approve labeling and promotional materials to ensure compliance with local regulations
  • Represent Regulatory Affairs in project teams, supporting business objectives and compliance standards
  • Manage post‑market surveillance (PMS), field actions, and complaints in Singapore and Malaysia
  • Own and manage regulatory databases and reporting, ensuring accuracy and transparency
  • Provide regulatory intelligence to business units, strengthening collaboration and decision‑making
  • Support continuous improvement initiatives, including process optimization and digitization within Regulatory Affairs
  • Perform additional duties as assigned to support regulatory excellence

Requirements:

  • Bachelor’s Degree in Pharmacy, Science, or equivalent
  • Minimum 6 years of regulatory experience in the medical devices industry
  • Strong expertise in new registrations, license extensions, variations, and renewals, with mandatory experience in Class II devices and above
  • In‑depth knowledge of regulatory laws, acts, and evolving requirements
  • Solid understanding of GDPMD standards
  • Skilled in project management, multitasking, and prioritization
  • Excellent interpersonal, communication, and negotiation skills
  • Proficiency in technical systems (word processing, spreadsheets, databases, online research)
  • Ability to identify compliance risks and escalate effectively
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 13, 2026

Icon
Baxter - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Regulatory Affairs Specialist – Regional

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...
Location
Location
United Kingdom , London
Salary
Salary:
45000.00 - 50000.00 GBP / Year
thepeopleco.com Logo
The People Co.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of technical or regulatory experience in food, feed or ingredients
  • Highly analytical, and organised with keen attention to
  • Must be able to identify problems and provide systematic
  • Be able to multi-task and have excellent communication skills
  • Real team player – Must be able to work with senior and junior employees in a professional and inclusive manner
  • A high level of business English is essential
  • The successful candidate will be self-motivated
  • Strong administration skills on Microsoft Office Packaging on Windows
Job Responsibility
Job Responsibility
  • Ensure regulatory compliance with food and feed safety, quality and defence as it relates to UK, EU and GFSI (BRC) requirements, Organic, Halal, FAMI QS and Kosher
  • Monitor changes in legislation and regulatory requirements, proactively assessing the impact on business and updating the senior management team's compliance protocols as necessary
  • Support the development and implementation of regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions ensuring compliance to but not limited to Allergens, REACH, Novel food, Packaging Food Contact Materials, Food Law and labelling, Feed laws and labelling, Residues and Contaminants, Natural and Botanical ingredients etc
  • Provide regulatory review of product compliance when an in-depth analysis/review is needed for the quality department. Example of review provided: Novel food status, specific application status, claims, labelling
  • Coordinate with authorities for all work required, such as authorisation and licenses
  • Support the design and maintenance of Prinova Specification, ensure all information is correct and meets relevant EU regulation requirements
  • Provide training for the quality and technical teams in Europe
  • Actively support QA department tasks according to workload and priorities, as required
  • Provide support to the commercial and marketing team to verify regulatory compliance
  • Assisting, as required, in the management of crises and incidents as part of the management team
Read More
Arrow Right

Senior Patient Safety Specialist

Location
Location
Philippines , Manila
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Expert knowledge of drug safety regulations and pharmacovigilance processes
  • Strong analytical and problem-solving abilities
  • Excellent communication and presentation skills
  • Superior organizational and time management capabilities
  • Proficiency with pharmacovigilance systems and databases
  • Proven experience in safety case management and regulatory reporting
  • Proficiency with safety databases and data analysis
  • Strong knowledge of ICH guidelines and regional requirements
  • Demonstrated mentoring abilities and process improvement skills
  • Experience in pharmaceutical or healthcare environments
Job Responsibility
Job Responsibility
  • Maintain expert-level knowledge of safety profiles, labeling, and global regulations
  • Lead development of project-specific procedures and workflows
  • Provide technical guidance to junior team members
  • Prepare for and participate in audits and inspections
  • Analyze metrics and drive continuous improvement
  • Collaborate with cross-functional teams on safety deliverables
  • Identify risks and recommend mitigation strategies
  • Ensure compliant documentation and archiving
  • Lead project management including safety procedure development and database setup
  • Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)
Read More
Arrow Right

Senior Corporate Counsel, Infrastructure Legal Affairs

Microsoft's Corporate and External Legal Affairs (CELA) organization has an open...
Location
Location
United States , Redmond
Salary
Salary:
147000.00 - 258000.00 USD / Year
https://www.microsoft.com/ Logo
Microsoft Corporation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Juris Doctor Degree or international equivalent degree AND 6+ years experience as a practicing attorney OR equivalent experience
  • Active license to practice law in a jurisdiction and capable of meeting admission requirements in relevant jurisdiction
  • 8+ years experience as a practicing attorney with a background in global regulatory analysis or complex infrastructure deals
  • Demonstrated experience advising on data center development and/or cutting-edge data center technology
  • Experience working as in house counsel
Job Responsibility
Job Responsibility
  • Serve as a legal advisor for the Regional Expansion group in the Cloud Operations + Innovation division of Microsoft, providing legal counsel on the data center regulatory environment on a market-by-market basis
  • Identify and anticipate highly complex legal and/or other business risks
  • Provide input on proposals for regulatory evolutions related to data center infrastructure
  • Develop strong, trusted advisor relationships with business clients and executives
  • Collaborate with specialists in trade, privacy, and other regulatory domain subject matter exports, government affairs, finance, and communications teams
  • Embody our culture and values
  • Develop and implement solutions that anticipate and mitigate risks
  • Manage and develop relationships with outside counsel and clients to create strategic and innovative solutions that address issues and achieve business objectives
  • Provide feedback and evaluate process improvements including the development and deployment of AI tooling that increase efficiencies
  • Fulltime
Read More
Arrow Right

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...
Location
Location
India
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Sound knowledge of drug safety and the drug development process
  • Knowledge of and ability to interpret and apply global safety regulations
  • Experience in data analysis and evaluation of safety data
  • Good presentation skills
  • Analytical and problem-solving skills
  • Clear understanding of the regulatory submission process
  • Proficient in database/literature searches
  • Excellent interpersonal skills
  • Excellent verbal / written communication skills
  • Excellent organizational and prioritization skills
Job Responsibility
Job Responsibility
  • Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
  • Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
  • Assist in development of project specific safety procedures, workflows and templates
  • Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
  • Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
  • Delegate work as appropriate to Drug Safety Assistants
  • Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
  • Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
  • Mentoring new recruits in the team, if required
  • Archiving the source documents and relevant emails as required
Read More
Arrow Right
New

Logistics Agent

At Bombardier, we design, build and maintain the world’s peak-performing aircraf...
Location
Location
United States , Wichita
Salary
Salary:
Not provided
bombardier.com Logo
Bombardier
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 0-5 plus years related experience
  • Business related Bachelor’s degree (preferred)
  • Basic knowledge of MRP principles and supply chain management
  • Basic knowledge of process improvement methodology and application, for example, Six Sigma and Lean Manufacturing initiatives
  • Basic knowledge of departmental policies and practices
  • Working knowledge of MS Office, email and web-based applications
  • Planning and organizational skills necessary to prioritize and coordinate workload within a multiple project setting
  • Verbal and written technical and business communication skills
  • Contract interpretation skills necessary to read and interpret supplier agreements
  • Negotiation skills necessary to secure, for example, price, delivery schedule, and performance metrics with internal and external suppliers
Job Responsibility
Job Responsibility
  • Adhere to Bombardier General Work Requirements
  • Provide placement of internal and external orders for components
  • Harmonize, communicate, and resolve issues relating to internal and external suppliers not meeting schedule requirements
  • Assist in the Receipt of shipments including unboxing items, gathering paperwork and making the appropriate transactions
  • Maintain and adhere to master data information of internal and external suppliers, for example, price, lead times, and order policies
  • Develop recommendations for parts or program change management process, for example, price, lead times, make-buy, and part number changes
  • Maintain and adhere to inventory-level and capacity targets
  • Initiate and coordinate with other departments such as Engineering, Methods, Quality Assurance, Operations and other Material Logistics functions to resolve problems concerning delivery, component discrepancies, and lead times with internal and external suppliers
  • Participate in special projects, for example, certification effort, Six Sigma, and Natural Work Team
  • Participate in improvement projects related to the Demand to Supply process, including but not limited to, cost reductions, system modifications and data management
What we offer
What we offer
  • Insurance plans (Dental, medical, life insurance, disability, and more)
  • Competitive base salary
  • Retirement savings plan
  • Employee Assistance Program
  • Tele Health Program
  • Fulltime
Read More
Arrow Right
New

Event Steward

We are looking for Event Stewards to work across Coventry and the Midlands; and ...
Location
Location
United Kingdom , Coventry
Salary
Salary:
12.21 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience working as an Event Steward
  • Previous customer service experience
  • Good level of verbal and written English
  • Ability to react calmly in high pressured situations
  • Must be over 18 years of age
  • DBS Certificate
Job Responsibility
Job Responsibility
  • Welcoming all visitors to the venue
  • Dealing with any queries and offering additional information regarding the event
  • Checking access passes (where applicable)
  • Helping to direct flow of foot traffic
  • Offer an excellent level of customer service to ensure the smooth running of the event
  • Being the eyes and ears of the event and ensuring the safety team have the information they require
What we offer
What we offer
  • Upskilling opportunities
  • Flexibility to work around current commitments
  • Opportunity to work at a multitude of events such as sporting events, concerts, and festivals
  • Parttime
Read More
Arrow Right
New

Safety specialist

We are seeking EHS Specialist. You will be responsible for inspecting and evalua...
Location
Location
Australia , Alice Springs
Salary
Salary:
Not provided
amentum.com Logo
Amentum
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Diploma in safety or related field, or equivalent
  • 1 to 3 years’ experience in occupational safety
  • Must possess working knowledge of the Australian Work Health Safety Act 2011
  • Drivers License
  • 1 to 3 years – in a similar role
  • Ability to read, analyse, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
  • Ability to write reports, business correspondence, and procedure manuals
  • Ability to effectively present information and respond to questions from groups of managers, customers, and the public
  • Ability to lift items up to 10kg independently
  • Frequent requirements to walk, sit, use hands to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl
Job Responsibility
Job Responsibility
  • Instills a safety-first mentality within respective work areas and a culture that achieves low accident rates and minimal lost-time injuries
  • Perform incident investigations to include root cause analysis and provide assistance with developing and implementing appropriate corrective actions
  • Provide or coordinate safety training for employees as required
  • Develop and lead safety toolbox talks on relevant EHS material
  • Develop and maintain the safety, health and environmental program recordkeeping and reporting system
  • Support the development, implementation and data capture for leading and lagging indicators to include corrective actions resulting from workplace inspections, process improvements, employee observations, EHS related incidents/injuries/near misses, etc
  • Assist site Working Groups with the development of Safe Work Procedures, task hazards analysis, safe work method statements (SWMS), and other risk assessments
  • Provide coaching, mentoring and advising to all levels of the workforce to promote a safe work culture
  • Conduct and document periodic workplace inspections to identify hazardous conditions and regulatory non-compliance issues
  • Work with relevant working groups to resolve issues identified
  • Fulltime
Read More
Arrow Right
New

Housekeeping Assistant

Situated in Nairn, Manor Care Centre offers a peaceful environment where residen...
Location
Location
United Kingdom , Nairn
Salary
Salary:
12.27 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience from a housekeeping or domestic cleaning role
  • Basic understanding of infection control, COSHH, and compliance standards
  • Ability to follow instructions and cleaning schedules
  • Ability to report issues
  • Ability to work well with others in a professional and courteous manner
  • Pride in your work
  • Attention to detail
  • Time management
  • Respectful communication
  • Ability to work well as part of a team or on your own
Job Responsibility
Job Responsibility
  • Maintaining the highest levels of cleanliness in public areas and bedrooms within the home
  • Responsible for the wash, dry, iron and put away of laundry
  • Ensuring that our residents' care home facilities, public areas and rooms are maintained to the highest cleaning standards
  • Replenish and maintain supplies in both resident rooms and common areas
  • Communicate effectively with residents and colleagues to address needs and concerns
What we offer
What we offer
  • Competitive benefits
  • Overtime rates
  • Parttime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Germany Jobs Ireland Jobs Poland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
CrawlJobs Group
ITFlashcards AllDevBlogs
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy