Regulatory Affairs Manager Job at iconplc (Seoul)

Employee in quality management and/or regulatory affairs

As a professional QM/RA associate, you will be responsible for tasks in Quality ...

Location

Austria , Salzburg

Salary:

Not provided

Brainlab

Expiration Date

Until further notice

Requirements

Experience or training in Quality Management, preferably in the medical device sector (ISO 13485) or any industry with high regulatory standards
Knowledge of EU MDR (Medical Device Regulation) and experience with Class II or higher medical devices is an advantage
Familiarity with clinical evaluations and post-market surveillance processes under MDR guidelines is highly desirable
Knowledge of international regulations and certifications for medical devices is a plus
Fluent in German and English (written and spoken)
Flexible, team-oriented, and eager to work in an international environment

Job Responsibility

Support and collaborate across all areas of Quality Management (QM)
Ongoing control, improvement, and optimization of quality management processes and standards
Assist in creating and reviewing deviation reports, risk management plans, and CAPA (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions
Ensure the implementation and monitoring of regulatory requirements for medical devices
Assist with international product certifications and approvals
Liaise with regulatory bodies and authorities, including correspondence with notified bodies (globally)
Support clinical evaluations, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards
Participate in post-market surveillance activities, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness
Support internal and external audits as well as supplier audits
Assist R&D with documentation and support the development process

What we offer

A motivating work atmosphere in a young, dynamic team
An exciting and varied scope of assignments customized for your skills and interests
The opportunity to grow with us, be directly involved and participate in our company’s success
A secure, permanent full-time contract
Generous social benefits within our culturally diverse enterprise
Freshly-cooked meals and healthy snacks provided daily
Good public transport connections and parking facilities available
Flexible working hours
Support for daily obligations (childcare, etc.)

Fulltime

Regulatory Affairs Manager

The RA Manager supports Global Reg Teams in the development and execution of glo...

Location

United States

Salary:

51.00 - 75.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Degree in health or life sciences, including chemistry, molecular biology, or similar. PhD preferred, Masters/Bachelors acceptable with relevant experience
4+ year experience
Nonclinical / Clinical Regulatory Affairs experience preferred

Job Responsibility

Support the development of the nonclinical / clinical regulatory strategy and plan
Assist with selected planning, document development and meeting execution activities in preparation for HA meetings / interactions
Participate in Study Execution Teams for assigned products and identify relevant regulatory considerations for discussion with RNC Lead
Collaborate with CROs that are contracted to perform regulatory submissions/HA interactions for global clinical trials
With oversight by RNC lead, develop and coordinate the core nonclinical / clinical content of regulatory submissions
Responsible for ensuring high quality nonclinical/clinical content that adheres to regulations and guidances
Lead the maintenance of IND/CTAs throughout the life of the studies (e.g., annual reports)
Assist with the preparation of HA submission packages including but not limited to compiling relevant materials (Protocols, Annual Reports, Briefing Books, etc.) and completing regulatory documents/forms for internal review
Collaborate with Reg PM to create and align submission timelines
Collaborate with Reg Ops to provide final documents and QC published outputs for submissions to HA

What we offer

discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans

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

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

Regulatory Affairs Manager

In this vital role you will work to ensure that Amgen acquires and maintains all...

Location

United Kingdom , Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Scientific Degree and demonstrated experience in a similar role
Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for clinical trials, MA, post approval changes, extensions and renewals.
Knowledge of drug development
Knowledge of and experience in regional regulatory environment
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and prevent potential issues

Job Responsibility

Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
Under general supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
Support regional label negotiation activities
Under general supervision participate in the development, and execution of regional regulatory product strategies
Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Under supervision evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labelling

What we offer

Growth opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

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 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

Regulatory Affairs Manager

As an active member of the Regulatory Affairs team, this position will participa...

Location

United States , New York

Salary:

132000.00 - 150000.00 USD / Year

Harry's

Expiration Date

Until further notice

Requirements

B.S. Chemistry or related science
3+ years of experience in a Regulatory Affairs position in cosmetic /personal care industries
Track record of executing cosmetic, OTC, and/or general product regulatory requirements in global markets
Track record of executing cosmetic regulatory requirements in global markets
Delivery and result focused, with high level of attention to detail and strong work ethic
High accuracy and reliability on assigned tasks
Demonstrated organizational agility - effective in working both independently and as part of a team with diverse groups of people at various levels within the organization
Excellent communication and organizational skills with the ability to meet project deadlines
Ability to function in a fast-paced environment
Demonstrates an immediate sense of urgency as well as flexibility

Job Responsibility

Oversee activities required for international and domestic compliance and registration to open and maintain market access, including import/export documentation, and all related activities
Lead regulatory intelligence and market entry strategy for new countries by researching and interpreting cosmetic regulations, registration pathways, labeling requirements, and ingredient restrictions to provide actionable guidance to cross-functional partners for successful product launches in new markets
Oversee drug product listing registration, annual renewals and establishment documents for all OTC products
Ensure all aspects of Regulatory compliance are reviewed and approved prior to market launch, working directly with cross functional teams (PD, R&D, Brand, Retail, Sourcing, PM). Scope includes: formulation, claims, packaging, artwork, registration, etc.
Work closely with third party partners and commercial teams to support international registrations
Assist in regulatory review of artwork for accuracy and compliance
Keep abreast of new Regulatory changes in all target markets globally and new product regulations and guidelines and ensure adherence throughout the product life cycle
Track new and upcoming regulatory changes for all target markets globally and present findings as needed to relevant cross functional departments
Verify documentation accuracy, consistency, and compliance
Assist with general product questions, regulatory inquiries, and questionnaires

What we offer

Medical, dental, and vision coverage
401k match
Equity in Mammoth Brands
Flexible time off and working hours
Wellness and L&D stipends
4 weeks sabbatical after 5 years, 6 weeks after 10 years, and 8 weeks after 15 years
20 fully paid weeks off for parents who give birth, or 16 fully paid weeks off for all other paths to parenthood
Fun IRL and virtual events including happy hours, team building events, and parties on our rooftop
Free products from all of our brands
Bagels on Wednesdays and lunch on Thursdays

Fulltime

Regulatory Affairs Manager

iconplc

Location:
South Korea , Seoul

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 15, 2026

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