Senior Regulatory Sciences Specialist Job at Pfizer (Taipei)

Senior Specialist, Regulatory Affairs

At Baxter, we believe every person—regardless of who they are or where they are ...

Location

United States , Deerfield

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a scientific, life sciences, or related technical field
2+ years of regulatory experience
Strong understanding of Veeva software (RIM and Promo Mats) systems
Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
Strong analytical skills, including digital competency
Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
Proofreading and editing skills
Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and problem solve

Job Responsibility

Under general supervision, responsible for Veeva RIM, Promo Mats system ownership
Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
Working with project teams on various data initiatives, addressing data challenges and gaps in current system
Identify areas for improvement/modification
Compile regulatory documents for FDA 2253 submission. Which includes tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements
Develop training material and liaise with cross function teams
Understand internal global processes supporting Regulatory systems
Coordinates and drives deliverable preparation
develops and maintains process models using standard methods and tools
manages and tracks communications, metrics, and reporting-related processes

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Specialist, Regulatory Affairs

The Senior Specialist resides within the Global Regulatory Affairs Systems Group...

Location

United States , Deerfield

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific, life sciences, or related technical field
2+ years of regulatory experience
Strong understanding of Veeva software (RIM and Promo Mats) systems
Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
Strong analytical skills, including digital competency
Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
Proofreading and editing skills
Ability to contribute to multiple projects from a regulatory affairs perspective
Ability to multitask and problem solve
Applicants must be authorized to work for any employer in the U.S.

Job Responsibility

Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
Working with project teams on various data initiatives, addressing data challenges and gaps in current system
Identify areas for improvement/modification
Compile regulatory documents for FDA 2253 submission
Develop training material and liaise with cross function teams
Understand internal global processes supporting Regulatory systems
Coordinates and drives deliverable preparation
develops and maintains process models using standard methods and tools
manages and tracks communications, metrics, and reporting-related processes
Develops, executes and implements business processes for data integration, maintenance and remediation

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Regulatory Specialist

At GSK, we unite science, technology, and talent to get ahead of disease togethe...

Location

India , Bengaluru

Salary:

144750.00 - 241250.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Chemistry, pharmacy or other related biological science or technical bachelor's degree
English language skills
Knowledge of drug development and manufacturing and supply processes
Knowledge of worldwide CMC post-approval regulatory requirements
Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager
Service orientation, customer-focused

Job Responsibility

Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms
Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers
Will serve as a mentor/trainer for new team members
May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department
Independently and confidently executes agreed dossier strategy
Independently manages multiple project simultaneously
assignments will range in complexity but more complex work is expected
Independently completes data assessment to ensure dossier is fit for purpose
Identifies risks associated with submission data and information packages
Escalates issues with line manager that have business impact

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Annual bonus
Eligibility to participate in our share based long term incentive program

Fulltime

Senior Regulatory Specialist - Biocides

A trusted partner at nearly three million customer locations, Ecolab (ECL) is th...

Location

Poland , Kraków

Salary:

Not provided

Edgerton Dental Clinic

Expiration Date

Until further notice

Requirements

PhD or MSc degree in Natural Science or Life Science (Chemistry, Toxicology, Ecotoxicology or similar)
At least five years of professional experience in Biocides Regulation (EU) 528/2012 or other European chemical regulations, such as REACH, is required.
Proven project management, communication and problem-solving skills in a regulated environment
Ability to prioritize tasks effectively and excellent time management skills
Demonstrated success coordinating activities with internal businesses and external customers or business partners
Excellent English skills (written and spoken)

Job Responsibility

Develop regulatory strategies to safeguard assigned biocidal active substance portfolio in Europe
Facilitate business growth by obtaining active substance approvals and driving innovation initiatives in accordance with the Biocidal Product Regulation (BPR)
Organize and lead cross-functional authorization projects addressing key business needs with assigned resources
Liaise with notified bodies and competent authorities with tasks related to the BPR and lead with quick response on short-term requests.
Review and document budget, internal data, contracts and data sharing agreements to ensure Regulatory and Legal compliance
Monitor, communicate and implement changing EU and biocide guidance
Provide regulatory surveillance (i.e. intelligence) and business impact assessment of emerging regulations

What we offer

Attractive salary (Base pay & Variable Plan) and benefits package (private medical care, life insurance, stock purchase, lunch subsidy, sport cards)
Flexible working arrangements with hybrid model of work (approx. 60% from the office and 40% from home)
Thrive in our matrix organization, working across Europe with various teams and cultural backgrounds
Strong teamwork and diverse interactions
Personalized plans with rapid progression
Professional growth supported by active committee for different career levels
High employee satisfaction and responsive feedback
Continuous learning and technical training incl. subject matter experts’ trainings, soft skills and management trainings and LinkedIn learning
Assistance for international candidates and candidates living outside of Krakow
Social events such as family events and charity auctions

Fulltime

Senior Regulatory Specialist

The Senior Regulatory Specialist is responsible for planning, managing, and impl...

Location

United States , Burnsville

Salary:

100000.00 - 130000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/ training
5+ years’ Regulatory and/or Compliance-related experience in a regulated industry
Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards
Experience with preparation, submission, and approval for medical devices is required
Strong communication skills, both verbal and written
Strong analytical and problem-solving skills, as well as a good background in the medical device development process
Demonstrated ability to effectively manage multiple projects and priorities
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat

Job Responsibility

Develops domestic and international strategies for regulatory approval of company products
Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country-specific product registrations
Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review
Reviews product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings
Represents RA on cross-functional product development, manufacturing, and clinical support teams and provides regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers
Provides technical reviews of supporting documentation for inclusion in regulatory filings
Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting
Represents RA on other cross-functional projects, which may include process changes and continuous improvement efforts
Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision
Performs other related duties and responsibilities, as assigned

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

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

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Senior Regulatory Sciences Specialist

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