Senior Manager Quality Compliance External Affairs Job at Amgen (Dun Laoghaire)

Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Location

United Kingdom , Cambridge; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
Previous experience supporting regulatory authority inspections of pharmacovigilance activities
Experience of leading and/or supporting process improvement initiatives
Previous leadership or mentoring experience is ideal

Job Responsibility

Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality
Ensure proactive identification of issues relating to processes, programs, and external relationships, escalate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation
Assess and manage risks including providing input into the development of the annual GPvP audit plan
Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers
Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information
Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs
Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers
Support inspections and external audits, including preparing, conducting, and closing out response reviews
Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews
Develop long-term remediations and process improvements through Root Cause Analysis (RCA)

What we offer

Vast 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
Ability to work flexibly from home with occasional office work

Fulltime

Senior Compliance Manager & MLRO

As Senior Compliance Manager & MLRO, you will be Airwallex’s key FCC lead for Ne...

Location

New Zealand , Auckland

Salary:

Not provided

Airwallex

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Law, Finance, Business or a related field
8+ years of financial crime compliance experience in a financial institution or payment services / fintech environment
Demonstrated auditing or assurance background and prior experience interacting with regulators, ideally including the Department of Internal Affairs (DIA) or another New Zealand AML/CFT supervisor
In‑depth familiarity with New Zealand laws and regulations, particularly the Anti‑Money Laundering and Countering Financing of Terrorism Act 2009 and associated regulations and guidance
Hands‑on experience with STR and PTR investigation and filing, and with managing transaction monitoring and name‑screening escalations end‑to‑end
Strong stakeholder management skills, with the ability to credibly engage and challenge senior internal stakeholders and external partners while role‑modelling Airwallex values and behaviours
Excellent written and verbal communication skills in English, including the ability to draft clear regulatory submissions, board‑level materials and investigation narratives

Job Responsibility

Program leadership: Own and continuously develop the Financial Crime Compliance (FCC) framework for Airwallex’s New Zealand business, aligning it with the Airwallex global compliance framework and the requirements of the Anti‑Money Laundering and Countering Financing of Terrorism Act 2009 (AML/CFT Act) and related regulations
Regulatory liaison: Lead day-to-day management and execution of Airwallex’s AML/CFT regulatory interactions, examinations and ad‑hoc requests in New Zealand, including managing relationships with the DIA and any other relevant local authorities and industry bodies
STR/PTR oversight and BAU casework: Oversee and, where required, execute BAU financial crime activities, including enhanced due diligence (EDD) reviews, transaction monitoring escalations, name‑screening alert escalations, and the investigation and filing of Suspicious Transaction Reports (STRs) and Prescribed Transaction Reports (PTRs) in accordance with New Zealand requirements
Stakeholder management: Represent Airwallex with critical external stakeholders, including regulators, banking and payment partners, and other counterparties, ensuring consistent, transparent and well‑governed engagement on FCC matters
Advisory to the business: Provide clear, pragmatic FCC and AML/CFT advice to Commercial, Product, Operations, Legal and other teams on customers, products, features and go‑to‑market initiatives, helping to balance growth and risk in line with our global and local risk appetite
Reporting and governance: Develop and maintain regular FCC reporting to senior management and relevant governance bodies (e.g. local leadership, audit/risk committees and the Board as appropriate), including key risk indicators, incident updates, remediation status and thematic insights
Audit, reviews and remediation: Coordinate responses to internal audits, independent reviews, regulatory inspections and self‑assessments related to AML/CFT and sanctions, ensuring issues are clearly owned, tracked and remediated within agreed timeframes
Internal controls and procedures: Lead the design, implementation and ongoing monitoring of internal FCC controls, including policies, standards, procedures and quality assurance over FCC Operations and Hub teams supporting New Zealand activity
Governance and oversight of operations: Provide robust oversight and challenge over the FCC Hub and Operations teams that support New Zealand (e.g. KYC, screening, transaction monitoring), ensuring procedures are fit‑for‑purpose for the New Zealand risk profile and regulatory obligations
Training and culture: Champion a strong compliance and conduct culture in New Zealand by driving targeted AML/CFT training, coaching and awareness initiatives for relevant teams, and by embedding FCC considerations into key business processes and decisions

Fulltime

Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

This position is responsible for leading CMC regulatory activities for investiga...

Location

United States; Belgium; Italy; United Kingdom , Collegeville; Wavre; Durham; Siena; London; Waltham

Salary:

144375.00 - 240625.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences or related field
Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise
Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
Two or more years of experience completing project management tasks.

Job Responsibility

Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements
Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies
Mentors or trains staff
May have direct line management responsibility
Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate
Provides strategic direction, data assessment and conclusions within and across departments
Able to establish organisational networks (internal and external understanding departmental constraints/pressure within a highly complex organisation
Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment)
May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs)
Has accountability for submission content

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
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation

Fulltime

Senior Manager, Central Regulatory Affairs

The Sr. Manager - Central RA is a pivotal senior leadership role based out of Ba...

Location

India , Bangalore

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related discipline
12+ years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with significant people management and team development
Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals
Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders
Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives

Job Responsibility

Develop and implement global regulatory strategies for Baxter products (both Drugs and Devices) aligned with business objectives to support product lifecycle spanning timely Initial /Geo-expansion/ Change controls and Variations registrations enabling speedy commercialization across diverse markets
Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements
Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions
Lead the preparation and submission of regulatory documents, including lifecycle management submissions, to regulatory authorities globally
Ensure that all submissions are accurate, complete, and compliant with regulatory requirements
Engage and collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to gather necessary information and ensure alignment
Oversee the preparation, review, and submission of both Drug and Device Lifecycle management regulatory filings (e.g., Initial and Geo-expansion registrations, change controls, Variations, Tender support, Acquisition Integration /Divestiture related Legal Entity name changes etc.) to health authorities across global markets
Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions
Establish and maintain standardized regulatory processes, procedures, and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA
Generate future readiness with implementation of best practices and continuous improvement initiatives to optimize regulatory operations and ensure consistency across regions for registrations, Change Control Management, tender Support, Geo-expansion/Initial registrations

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

PMO Sr. Manager, Quality, Regulatory & Safety

The Project Manager, Regulatory, Safety & Quality will act as a strategic partne...

Location

Italy , Milano; Bologna; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

8+ years of experience in biopharma, life sciences, consulting, or strategy roles
Solid exposure to Regulatory Affairs, Pharmacovigilance/Safety, Quality, or closely related development functions
Experience working in highly regulated environments is required
Advanced degree preferred (PhD, MSc, MD, PharmD, MBA, or equivalent), ideally with a scientific or regulatory background
Strong ability to lead through influence in complex, matrixed organizations
Excellent organizational, communication, and analytical skills
High level of discretion, integrity, and ability to manage sensitive and confidential information
Proven experience partnering with senior leaders and coordinating cross-functional initiatives
Solid understanding of regulatory, safety, and quality principles within drug development

Job Responsibility

Translate priorities of the Regulatory, Safety & Quality leadership into actionable plans with clear ownership, timelines, and deliverables
Coordinate the definition and monitoring of annual goals, KPIs, and functional business reviews across Regulatory, Safety, and Quality
Track progress of key initiatives (e.g. submissions, inspections readiness, safety governance, quality systems) and ensure alignment across internal and external stakeholders
Prepare, consolidate, and manage content for leadership team meetings, governance forums, and relevant committees (e.g. Safety Committees, Quality Councils)
Act as a thought partner to the Head of Regulatory, Safety & Quality in short- and long-term planning
Synthesize complex regulatory, safety, and quality information into clear summaries, dashboards, and recommendations to support decision-making
Serve as a central liaison between Regulatory, Safety, Quality, Clinical Development, Operations, Biometrics, and other relevant functions
Ensure timely follow-up and accountability on decisions and action items
Facilitate effective information flow with external partners, vendors, and consultants where applicable
Support and evolve governance frameworks related to Regulatory, Safety, and Quality (e.g. risk management, inspection readiness, compliance oversight)

Senior Regulatory Affairs Product Specialist

The Senior Regulatory Affairs Product Specialist serves as a key regulatory part...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Advanced experience with practical European Regulatory Affairs, including a good understanding of the following MA lifecycle activities within DCP, MRP and National procedures (preferably also other than URPL): post-authorisation variations impacting CMC, Safety and Product Information
different submission strategies (e.g. single, grouping, SuperGrouping, WorkSharing)
other RA activities such as renewals and PSURs/PSUSAs
CTD/eCTD documentation structure and lifecycle management
Knowledge and understanding of the following areas, European regulations and related guidance documents (e.g. management of documents, submissions, requirements): regulatory submissions across different markets and procedures, including the Centralised Procedure
Product Information authoring, editing and management
CMC documentation requirements
CTD and eCTD authoring, editing and lifecycle management
Able to perform other Regulatory Affairs activities with team support (e.g. PASS, PAMs, Centralised Procedure submissions)
Able to perform accompanying activities such as Artwork reviews/approvals and Prescribing Information preparation

Job Responsibility

Preparation and submission of required regulatory packages for designated products/countries, including variations and lifecycle activities
Authoring/updating of key regulatory documentation including CTD components and Product Information and leading review of other technical documents to ensure regulatory compliance
Development and implementation of regulatory strategy for required changes
Act as the contact within the business for regulatory advice and support related to designated products
Provide support and regulatory advice to key internal stakeholders including MS&T, Quality, Pharmacovigilance, Supply and other teams
Identification of any gaps in the regulatory documentation and conduction of any remediation necessary to achieve compliance
Communication with external stakeholders, including regulatory agencies, CMO's and third party service providers
Creation and maintenance of Regulatory Information Management systems and databases records and entries
Support of creation and maintenance of SOPs, working instructions describing regulatory and labelling processes and best practices to ensure compliance

What we offer

A fast-paced environment with broad exposure, giving you opportunities to develop professionally - even outside your core area of expertise
A culture that supports learning, celebrates success, and recognizes performance
Opportunities for driven and talented professionals to contribute to our exciting journey

Fulltime

New

Senior Associate, Labeling Compliance

The Senior Associate, Labeling Compliance will support the planning, coordinatio...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelorâ€™s degree or Masterâ€™s degree with 5 to 9 years of directly related experience in Regulatory Affairs, labelling compliance, artwork management, quality, or a related pharmaceutical or biotechnology function
Equivalent combinations of education and relevant experience may also be considered

Job Responsibility

Coordinate day-to-day labelling activities to support timely and compliant implementation of approved labelling changes across EU and global markets
Manage labelling change requests, track deliverables, monitor timelines, and maintain accurate records in applicable labelling, artwork, or document management systems
Serve as an operational point of contact for labelling activities, providing guidance to internal stakeholders on labelling processes, document requirements, formats, and timelines
Ensure labelling updates are aligned with approved Product Information, internal procedures, quality standards, and market-specific implementation requirements
Identify potential compliance risks, delays, inconsistencies, or documentation gaps and escalate issues to the appropriate stakeholders for timely resolution
Support EU labelling activities across applicable procedures, including centralised, decentralised, mutual recognition, and national procedures, as relevant
Coordinate updates to EU Product Information components, including the Summary of Product Characteristics, Package Leaflet, outer labelling, inner labelling, mock-ups, and related packaging text
Support alignment of labelling content with approved Marketing Authorisations, regulatory commitments, internal procedures, and country-specific requirements
Coordinate with regional and local Regulatory Affairs contacts to gather requirements, clarify expectations, resolve queries, and support implementation of approved labelling changes
Track EU labelling milestones, review comments, approvals, and implementation status to ensure visibility across stakeholders and support delivery against agreed timelines

Fulltime

Select Country

Senior Manager Quality Compliance External Affairs

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?