Intern - Regulatory Affairs Job at Edgerton Dental Clinic (Kraków)

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...

Location

Netherlands , Utrecht

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
Knowledge of applicable laws and regulations to ensure full compliance
Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
Proficiency in speaking, comprehending, reading and writing Dutch is required
Proficiency in speaking, comprehending, reading and writing English is required
Ability to think strategically & execute tactically

Job Responsibility

Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
Collaborate with commercial, medical and market access to realize cross-functional objectives

What we offer

Competitive salary and benefits package
Opportunities for professional growth and development

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Intern, regulatory information management and technology

The BioMarin Summer Internship Program will enable students to gain valuable exp...

Location

United States

Salary:

24.00 - 27.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Knowledge of the Regulatory Affairs submission process
Proficient computer skills and working knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
Excellent interpersonal, written and verbal communication skills
Strong organizational skills with ability to prioritize and manage tasks in a fast-paced environment
Ability to work independently and collaboratively
Student pursuing a Bachelor’s degree in computerized systems or life sciences (or in related fields of study)
Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program
Must be available to work 40 hours a week
Must be authorized to work in the United States without visa sponsorship

Job Responsibility

Provide Regulatory Data Management and Regulatory Systems Usage/Implementation assistance for Global Regulatory Affairs RIMT group
Utilizing Information Management skills, provide Business Analysis to assist in enhancing existing Regulatory Information management data quality
Assess and reconcile regulatory details associated with Regulatory Health Authority Applications to support both Marketing and Investigational Drug Product authorizations
Providing support for Operational Change Management activities relating to technology improvements related to the Veeva RIM platform

What we offer

Paid hourly wage
Paid company holidays
Sick time
Apply skills and knowledge learned in the classroom to on-the-job experiences
Comprehensive, value-added project(s)
Develop skills specific to your major
Opportunities for professional development by building relationships and learning about other parts of the business
Participate in company all hands meetings, monthly community lunches
Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
Access to Employee Resource Groups

Fulltime

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Manager Regulatory Affairs

Beam is seeking a Manager Regulatory Affairs to progress a broad portfolio of ad...

Location

United States , Cambridge

Salary:

125000.00 - 155000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS in a medical or scientific field required
Strong grasp of drug development lifecycle and strategy
A minimum of 8 years of experience working in Regulatory Affairs
Knowledge of US and global regulatory procedures and practices
Firsthand experience with regulatory document authoring and submission (e.g. IND, CTA, BLA, MAA, PIP)
Experience supporting teams through interactions with Regulatory Agencies and Health Authorities
Ability to develop and maintain collaborative working relationships with internal and external partners
Excellent written/verbal communication skills, attention to detail, organizational skills

Job Responsibility

drive the development of global regulatory strategy for Beam’s portfolio of advanced genetic medicines
Incorporate evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, orphan indications, breakthrough treatments and other relevant regulations
Maintain and update regulatory submission plans, timelines, and other core strategic documents
represent Regulatory Affairs on cross functional and project teams
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time

Fulltime

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Senior Manager, Regulatory Affairs & Quality Assurance, APAC

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets...

Location

Singapore

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific or technical discipline
6-10 years of experience in the medical device industry
Proven leadership experience with a track record in managing teams and developing long-term strategic initiatives
Strong written and verbal communication skills
Experience with regional or international regulatory submissions preferred
Strong computer proficiency
Understanding of regulatory requirements across major APAC markets
Familiarity with mandatory Quality Management System requirements across APAC
General knowledge of US FDA regulations (21 CFR, FDA guidelines) and EU CE marking processes is an advantage

Job Responsibility

Provide strategic Regulatory Affairs and Quality leadership for all APAC markets where Avanos operates
Partner with global and regional stakeholders to ensure full compliance with regulatory requirements, support business objectives, and strengthen the RA/QA capability across the region
Serve as an active member of the Global Regulatory & Clinical Affairs, Global Quality, and APAC Leadership Teams
Provide Regulatory and Quality leadership across all APAC markets
Recruit, build, and develop in-country RA/QA teams
Advise APAC cross-functional teams and Global RA & Clinical Affairs and Global Quality functions on regional regulatory requirements
Oversee the preparation, submission, and lifecycle maintenance of product registrations across APAC
Maintain regulatory databases
Direct the development and maintenance of regulatory systems and processes
Develop APAC regulatory strategies

What we offer

comprehensive and competitive range of benefits
health care benefits
retirement plans
work/life benefits

Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
English proficiency at professional level
Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
Assist external stakeholders in the regulatory process per country requirements
Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

Intern - Regulatory Affairs

Edgerton Dental Clinic

Location:
Poland , Kraków

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 03, 2026

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