Senior Regulatory Affairs Specialist – Regional Job at Baxter (Petaling Jaya)

Regulatory Affairs Senior Specialist

Summary: The role involves managing government affairs, regulatory compliance, l...

Location

Saudi Arabia , Western Province

Salary:

Not provided

Giza Systems

Expiration Date

Until further notice

Requirements

Affairs Management
Regulatory Compliance
Licensing
Administrative Relations
Relationship Building with Government Entities
Liaison with Government Bodies
Anticipating Regulatory Changes
License and Permit Management
Legal Coordination
Government Transactions Processing

Job Responsibility

Build and maintain active relationships with key government entities in the Western Region such as MISA, HRSD, ZATCA, Amanah, Balady, MOL, and others relevant to pulse's operations
Act as the official liaison and single point of contact between pulse and all government bodies in the region
Proactively anticipate regulatory changes and brief management on potential impact before they take effect
Manage the full lifecycle of all licenses, permits, and regulatory registrations for pulse's Western Region operations
Coordinate with the Legal team and external counsel on regulatory disputes, notices, or government inquiries
Oversee the processing of all official government transactions, ensuring accurate submission and follow-up

Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota. ICON plc is a world-leading healthca...

Location

Colombia , Bogota

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in Pharmaceutical Chemist or next to graduate required
Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry
Knowledge or awareness of current regional guidelines and regulations is preferred
Technical knowledge in the preparation of a dossier is desirable
Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets
Advanced English level

Job Responsibility

Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries
Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises
Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool
Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations
Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area
Ensure that IP labels are in adherence to country requirements and submitted where applicable
Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor
Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team
Preparation of electronic regulatory submission of post-registration requests, HMPs, Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field at MoH
Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...

Location

United Kingdom , London

Salary:

45000.00 - 50000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

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

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

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Job Responsibility

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region: Local Complaint Coordinator activity, Product Surveillance activity for Medicinal Products and Medical Devices, Field Action execution, Supplier & Distributor Management, Implementation of Baxter Quality System in the region and audit management, NCR, CAPA and Change Management, Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available

Fulltime

Senior QARA Specialist

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

Algeria , Algiers

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region
To ensure that RA processes are in place in his / her region

Job Responsibility

Local Complaint Coordinator activity
Product Surveillance activity for Medicinal Products and Medical Devices
Field Action execution
Supplier & Distributor Management
Implementation of Baxter Quality System in the region and audit management
NCR, CAPA and Change Management
Selling Authorizations and release of products according to local requirements
Ensure back up persons for critical processes in the region are appropriately trained and back up are always available
To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO 9001 and 13485 requirements.

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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)

Senior Director/VP of Medical Affairs

As the Senior Director / Vice President of Medical Affairs, you will be the scie...

Location

United States , New York

Salary:

180000.00 - 280000.00 USD / Year

Click Therapeutics

Expiration Date

Until further notice

Requirements

Advanced Degree Required: PharmD
15+ years of progressive leadership within the pharmaceutical, biotech, or medtech sectors, with a significant portion dedicated to Medical Affairs and HEOR
Prior experience as an MSL
Proven track record of leading medical launch readiness for first-in-class products or complex specialty therapeutics
Ability to translate complex clinical data into a compelling narrative that shifts provider behavior and therapeutic paradigms
Exceptional emotional intelligence and a track record of building and mentoring diverse, high-performing medical teams
Mastery of scientific storytelling
the ability to present to a room of specialists one hour and a board of investors the next

Job Responsibility

Serves as the scientific authority for CT-155, collaborating closely with the internal Medical Office to ensure clinical alignment
Architect and execute the overarching US Medical Affairs strategy, ensuring alignment between clinical goals and real-world provider needs
Establish and maintain high-level relationships with National and Regional Key Opinion Leaders (KOLs) to garner insights and build advocacy for the PDT category
Serve as the primary scientific spokesperson for the company at major congresses, advisory boards, and with healthcare system leadership
Establish strategic alliances with advocacy groups and caregiver networks to validate PDTs as a standard of care within the schizophrenia ecosystem
Build and lead a high-performing Field Medical team, establishing KPIs for scientific engagement, provider education, and territory management
Develop robust Medical Information systems to provide timely, accurate, and balanced responses to unsolicited requests for information from HCPs
Ensure all medical materials and field interactions adhere to the highest standards of compliance and regulatory guidelines
Generates evidence (RWE/OLE) to prove clinical value and economic impact for Marketing and Access usage
Leverage Real World Evidence (RWE) and Open Label Extension (OLE) data to create Budget Impact Models (BIM) and Cost-Effectiveness Analyses (HEOR)

What we offer

Competitive Salary with Annual Review
Cash Bonus
Stock Options
5% 401(k) matching
Medical
Dental
Vision
Life Insurance
Voluntary Benefits
Unlimited PTO

Fulltime

Senior Corporate Counsel, Infrastructure Legal Affairs

Microsoft's Corporate and External Legal Affairs (CELA) organization has an open...

Location

United States , Redmond

Salary:

147000.00 - 258000.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

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

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

Select Country

Senior Regulatory Affairs Specialist – Regional

Job Description

Job Responsibility

Requirements

What we offer

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