Senior Manager, International Regulatory Affairs Job at BioMarin Pharmaceutical (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

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

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

Business Performance Senior Manager

The Business Performance Senior Manager is a member of the Transformation Execut...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree (scientific area) and 10 years of directly related experience OR Bachelor’s degree (scientific area) and 12 years of directly related experience
Knowledge of Regulatory principles
Working with policies, procedures and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
General knowledge of national legislation and regulations relating to medicinal products
General awareness of the registration procedures/challenges in the region for CTAs, MAs and all lifecycle management activities
Knowledge and experience in the international regulatory environment relevant for product area and development stage
Understanding of drug development
Able to anticipate regulatory Agency questions and potential responses
Demonstrate strong teamwork ability

Job Responsibility

Represent GRAAS at cross-functional MAL and Business Development-related forums, providing strategic input and thought leadership
Form and lead sub-function teams for integration and licensing activities, ensuring alignment with strategic objectives
Drive strategic solutions to complex business problems, leading analyses and negotiations with key decision makers
Lead Regulatory workstreams across all deal phases
Serve as Lead for all product licensing work, including integrations into and transitions out of Amgen
Closely partner with Regulatory Affairs (RA) Therapeutic Area Integration Project Lead and advise/instruct them on end-to-end process and details of planning and execution of acquisition integration
Act as their delegate as needed in cross-functional meetings
Assist with pre-deal close GRAAS due diligence
Develop and manage GRAAS integration workplan
Draft and manage any new controlled documents unique to the integration, such as Quality Integration PLANs and bridging process GDEs

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Senior Risk and Compliance Manager

Senior Risk and Compliance Manager (m/f/d) to build and unite processes across b...

Location

Germany , Berlin

Salary:

Not provided

Project A Ventures GmbH

Expiration Date

Until further notice

Requirements

Several years of experience working in an asset management company, bank, insurance company, or auditing or auditing firm
Professional background in legal, commercial, or business administration, ideally with tax knowledge (including legal, administrative, or banking or insurance qualifications)
Experience in risk management and compliance including ESG knowledge (required) and experience with DORA (desirable)
Strong affinity for numbers, structures, and processes
Business-level proficiency in both German and English

Job Responsibility

Manage risk and compliance processes in a licensed asset management company with more than ten closed-end “Spezial-AIFs”
Strengthen the Risk Management & Regulatory Affairs Department through enhancing reporting and processes in the areas of risk management, ESG compliance, and outsourcing controlling
Actively communicate with external service providers and outsourcing companies, as well as with internal front- and back-office units
Conduct ESG due diligence on investments in portfolio companies while also supporting the Investment Team with ESG-related documentation
Create and continuously maintain SFDR disclosures and ESG policies
Drive the development of new and ongoing risk and compliance reporting
Continuously enhance risk management and regulatory compliance across multiple front and back office units
Be at the interface between Project A and its regulated UK subsidiary

Fulltime

Regulatory Data & Systems Manager

The Regulatory Data & Systems Manager will be responsible for facilitating syste...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies
Excellent oral and written communication skills
able to organize and present ideas in a convincing and compelling manner
Ability to operate effectively in a matrix environment
team player yet able to work independently with minimal direction
Familiarity with GxP requirements and systems validation
Life Sciences, Biotech or pharmaceutical industry experience preferred
Proven Veeva Vault knowledge
Bachelor’s degree and 2 years of directly related experience

Job Responsibility

System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements
Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices
Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives
Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

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Senior Manager, International Regulatory Affairs

Job Description

Job Responsibility

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