Senior Regulatory Affairs Product Specialist Job at Theramex (Warsaw)

Senior Product Specialist, Regulatory Affairs

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Extensive experience with practical European Regulatory Affairs
Good understanding of MA lifecycle activities within DCP, MRP and National procedures (Post-authorisation variations, submission strategies, renewals, PSURs/PSUSAs)
Knowledge of CTD/eCTD documentation structure and lifecycle management
Knowledge of European regulations and related guidance documents for Regulatory submissions, Product Information authoring, CMC documentation, CTD and eCTD authoring
Able to perform other Regulatory Affairs activities with team support (e.g., PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as artwork reviews/approvals and Prescribing Information preparation
Good interpersonal skills and effective problem-solving capabilities
Proactive, adaptable and comfortable working across multiple projects while maintaining high standards
High attention to detail with excellent organisational and time-management skills
Excellent written and verbal communication skills in English

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries
Authoring/updating of key regulatory documentation including CTD components and Product Information
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO’s and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

25 days holiday + 8 bank holidays
Private Health Insurance for employee and family members
Pension contribution: 10% company + 5% employee (auto-enrolled from day one)
Hybrid Working
Cycle to Work Scheme
Engaging employee experience to come together as a community: in-office events, shared learning and much more

Fulltime

Senior Regulatory Affairs Specialist – Regional

This role offers an exciting opportunity to provide regional regulatory support ...

Location

Malaysia , Petaling Jaya

Salary:

Not provided

Baxter

Expiration Date

Until further notice

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

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

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Senior Regulatory Affairs Specialist

Are you interested in the future of digital health and medical device innovation...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Master’s degree within natural sciences, computer science, engineering or similar
5-10+ years in regulatory affairs (preferably both software and hardware medical devices)
Global regulatory market experience (e.g. EU, UK, Switzerland and MDSAP)
Demonstrated experience applying and interpreting relevant guidance and standards across software and hardware medical devices, including: IEC 60601 series, ISO 14971, IEC 62304, IEC 82304
Strong knowledge of cybersecurity and the evolving regulations for digital health and AI/ML devices
Adaptable and open to change and adjustments in agile work environments
Global mindset and experience with work relations in different cultures

Job Responsibility

Ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices
Involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices
Ensuring global device registrations
Working closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants
Active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks

What we offer

An attractive healthcare package to keep you fit and well
Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
Good work/life balance e.g., work from home policy for up to 2 days per week
Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
Social clubs, monthly Friday social activities, as well as various in-team activities

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen; Brussels

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years experience, or demonstrable capability, in area of responsibility or similar field
advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
Ability to deliver on customer or internal projects / processes within daily work
ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
Structured and systematic and independent way of working
limited latitude within established set of procedures, may determine priorities with little supervision
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities
ability to lead small projects with clearly defined scope

Job Responsibility

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
Communicate with clients and Health Authorities in close cooperation with the respective lead
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
Support with strategy implementation and optimization
Comply with and support the maintenance of internal procedures
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead

Fulltime

Regulatory Affairs Senior Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

United States

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s Degree and 3-5 years’ experience in Regulatory Affairs
or equivalent combination of education and experience
Experience working in the pharmaceutical industry
Ability to prioritize and drive multiple projects
Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
Understanding of FDA and Canadian Regulatory Affairs procedures, submission formats as well as industry standards and guidelines
Previous hands-on experience with managing and preparing original applications, amendments, supplements, annual reports, etc. for various application types including IND/CTA, ANDA/NDS/NDA/BLA
Ability to maintain confidentiality and responsive to client needs
Ability to adapt under regularly changing conditions

Job Responsibility

Manages the preparation, assembly, publishing, and submitting of US and Canadian regulatory applications on behalf of PharmaLex clients
Supports key regulatory affairs consultants, by providing expertise and innovative solutions to clients and internal teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications
Drafts and manages regulatory submissions
Drafts and manages drug listing submissions, establishment registration submissions and preparation of SPL files
Coordinates regulatory fee payments on behalf of client
Maintains knowledge of changing regulatory requirements and advises teams as appropriate (Regulatory Intelligence)
Liaises with regulatory authorities on behalf of clients (e.g., US Agent)
Builds, develops and maintains working relationships with clients
Conducts issue resolution, communicates with the client and their functional areas to ensure that all issues are resolved in a compliant manner
Performs basic document management tasks including file transfer, storage, tracking, and archival

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Senior Principal Regulatory Affairs Specialist - Transfusion

As a Senior Principal Regulatory Affairs Specialist, you will perform regulatory...

Location

United States , Norcross

Salary:

Not provided

werfen

Expiration Date

Until further notice

Requirements

Bachelor’s degree (BS/BA) from four-year college or university
or equivalent combination of education and experience
RAC certification, preferred
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations
Ability to write reports, business correspondence and procedure manuals
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume
Ability to apply concepts of basic algebra and geometry
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist
Ability to interpret a variety of instructions furnished in written, oral, diagram, and schedule form

Job Responsibility

Coordinates preparation, review and submission of product applications (510(k), BLA, Medical Device Licence Applications/Amendments, and Technical Documentation
Prepares and maintains Technical Files (Technical Documentation)
Reviews and approves quality system documents to determine compliance with SOPs, quality system and regulatory compliance, and industry standards
Reviews and approves significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements
Maintain regulatory product files of information submitted in support of domestic and international registrations
Coordinates field action and vigilance activities for Werfen product lines and notifies appropriate regulatory agencies, affiliates and distributors
Performs tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks
Evaluates complaint and internal deviation report data to determine the need for Medical Device Reporting, field action or Biological Product Deviation reporting
Maintains compliance with Medical Device Listing requirements for Werfen products
Recognizes and elevates critical regulatory/compliance issues to RA management

Fulltime

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Senior Regulatory Affairs Product Specialist

Job Description

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