Regulatory Affairs Senior Manager Job at Randstad (Tokyo)

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

Senior Regulatory Affairs Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Scientific or Technical Discipline
4+ years of experience in an industry-related environment
Project management knowledge
Client-focused approach
Results orientation
Teamwork and collaboration
Excellent interpersonal and intercultural communication
Critical thinking and problem-solving
Proficiency in local language and extensive English knowledge

Job Responsibility

Works effectively in teams or independently within area of competence
Works within project guidelines as directed by project/technical leads
Prioritizes work to achieve project outcomes
Seeks performance improvement and feedback
Applies information from senior colleagues to complete assigned activities
Produces quality work meeting project lead and client expectations
May serve as Project Lead for small projects or Work Stream Lead on larger projects
Functions as main client contact and ensures accurate project reporting
Ensures team delivery meets client expectations for quality and timeliness
Implements risk identification and issue-escalation procedures

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Specialist

Senior 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 medicine, pharmacology, biomedical science or related scientific discipline, or equivalent
Minimum of 5 years of experience in the regulatory affairs field in medical device industry
Minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU
English proficiency at professional level
Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Basic knowledge of Reg. (EU) 2024/1689
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 medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports
Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends
Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis
Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint
Work with customers/users to gather information/data to support investigations and complaints management
Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications
Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas
Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance
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

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Corporate Affairs Senior Manager

We are seeking a dynamic and experienced Senior Manager of Corporate Affairs to ...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 6 years of Communications and/or Advocacy experience
Bachelor’s degree and 4 years of Communications and/or Advocacy experience
Fluent in Japanese and English
Proven experience in corporate communications, public affairs, or public relations or an adjacent field, within healthcare, pharmaceuticals, or biotechnology
Strong ability to understand business priorities and contribute to effective, strategic communication plans
Skilled at translating complex topics into creative yet compliant storytelling that aligns with commercial and corporate goals
Demonstrated success working in a multinational, matrixed organization, leading through influence and aligning diverse stakeholders
Proven ability to work cross-culturally across JAPAC and global teams
Understanding and appreciation of Japanese culture, landscape, and stakeholder expectations and communication approaches
Strong interpersonal skills and ability to work collaboratively across teams

Job Responsibility

Develop and deliver impactful product communications for launches of new medicines and expanded indications
Execute integrated communications strategies across media, emerging media, social and digital media to support corporate priorities, therapeutic areas, and key brand milestones and opportunities
Contribute to strengthening Amgen K.K.’s reputation through clear and authentic storytelling that resonates with key audiences across Japan
Develop and lead an advocacy engagement strategy that fosters trusted relationships with patient advocacy groups, to amplify the patient voice and support improved access to care
Drive disease and patient education communications in partnership with the Brand team including Marketing, Medical, and Value and Access functions
Collaborate with cross-functional partners, including Commercial, Government Affairs, Medical, Legal, Regulatory, to deliver communication activities that highlight Amgen’s commitment to innovation and contribution to Japanese society
Support internal communication efforts to help foster a connected, energized employee culture
Leverage generative AI and analytics tools to elevate quality, speed, and personalization of communications, improve working efficiency, and unlock actionable insights that inform strategies and optimizations
Coordinate best practices and learnings with colleagues in the JAPAC region and the Global Corporate Affairs team
Oversee vendors, when appropriate, ensuring high-quality execution, compliance, and budget discipline

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Manager, Global Medical Affairs (Menopause)

This role is pivotal in providing subject matter knowledge and expertise, develo...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Medical degree with GMC registration or equivalent international qualification or Master of Pharmacy with GPhC registration
Previous experience in Medical Affairs, Clinical Research, or Pharmacovigilance within the pharmaceutical industry
Very good understanding of Medical Affairs’ role as scientific enabler and strategic partner in a pharmaceutical company
Strong knowledge and subject matter in women’s health
Ability to cut through scientific complexity and to communicate precisely and clearly with different target audiences
Strong interpersonal and leadership skills and track record of expertise working in a cross-functional environment
Strong analytical and strategic thinking
Strong business acumen
Highest professional work ethics
Proven knowledge of the ABPI Code of Practice and codes of international associations of the pharmaceutical industry, with experience in reviewing and/or certifying materials

Job Responsibility

Develop and implement medical plans aligned with business objectives and manage associated budgets
Provide expert medical input across the product lifecycle, including: Evidence generation
Evidence dissemination (e.g. health care professional education programs)
Medical experts’ engagement programs (e.g. advisory boards)
Build and maintain relationships with international therapy area experts and medical-scientific professional societies
Act as a medical reviewer for promotional and non-promotional materials in line with the ABPI and international associations of the pharmaceutical industry codes as well as internal SOPs
Support regulatory and market access submissions with clinical content
Ensure compliance with all relevant regulations and contribute to continuous process improvement
Ensure operational excellence

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

Regulatory & Compliance Manager

Location

Egypt , Cairo

Salary:

Not provided

PaxeraHealth

Expiration Date

Until further notice

Requirements

Bachelor’s degree in compliance, regulatory affairs, business administration, or related field
At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry
Strong knowledge of industry regulations, quality standards (ISO), and compliance processes
Experience with obtaining ISO 9001, ISO 27000, ISO 13485, FDA, MDR
Excellent English Language
Excellent organizational, leadership, and communication skills
Ability to manage multiple projects and deadlines in a fast-paced environment

Job Responsibility

Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies
Lead efforts to obtain and maintain certifications (e.g., ISO 9001, ISO 27000, ISO 13485, FDA, MDR, and other relevant quality/compliance standards)
Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement
Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings
Monitor and interpret changes in laws, regulations, and industry standards
advise management on compliance implications
Implement and manage the company’s Quality Management Systems (QMS)
Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks
Conduct regular internal audits and assessments to evaluate compliance and certification readiness
Drive continuous improvement in quality processes through monitoring, feedback, and corrective action

Fulltime

Regulatory Affairs Senior Manager

Randstad

Location:
Japan , Tokyo

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
November 30, 2025

Expiration:
May 27, 2026

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