Director - Regulatory Intelligence Job at Waystone Governance Ltd. (Cashel)

Director - Regulatory Intelligence

Director - Regulatory Intelligence will oversee the Group’s external facing regu...

Location

United Kingdom

Salary:

Not provided

Waystone Governance Ltd.

Expiration Date

Until further notice

Requirements

An internationally recognised professional qualification
Strong academic background including at minimum a degree in law, business, economics or related field
Minimum of 10 years in professional services, preferably in the funds industry or law firm
Proven success and advancement within a risk, research, legal, compliance or portfolio management team
Networking skills, be highly motivated, and adept at building relationships
Capacity to apply real-world research to the Waystone’s business model
Client-facing background with strong presentation skills
Outstanding time management, organisational skills, oral/written communication skills, critical thinking and attention to detail is required
Must be able to work in a fast-paced environment including reporting and providing support to various members of the team
Strong MS Office Skills

Job Responsibility

Work closely with the Group Head of Horizon Scanning to agree effective methods of monitoring all relevant market and regulatory developments that may impact the Group’s clients, prospective clients, or delegates (in particular, Investment Managers) and maintain a centralised, easily accessible repository of regulatory updates and insights
Work with Waystone’s industry forum representatives to collate, assess and interpret global developments impacting our products and clients
Develop and deliver regular (monthly/quarterly) client newsletters summarising regulatory and market changes, tailored by client type and jurisdiction
Create and deliver targeted client briefings, webinars, and thought leadership on significant changes, including preparation of communications for LinkedIn and website publication by Group Senior Management or the Director of Regulatory Intelligence as appropriate
Partner with Product teams and Business Development and to translate regulatory change into new or enhanced product offerings
seeking opportunities for revenue growth
Coordinate with Compliance and Legal (local or Group as needed) to ensure consistency, accuracy and regulatory compliance in client communications
Support the training and enablement of internal teams to ensure regulatory changes are understood and leveraged effectively in client discussions
Support the Relationship Managers and Key Account Managers including with regulatory updates for use in Board Reports
Provide technical sales support through training the Business Development team in new regulation, new product offerings and changes to existing products, supported by impact and change analysis by the Group Head of Horizon Scanning

Parttime

Associate Director, Regulatory Affairs

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Deerfield, Illinois

Salary:

176000.00 - 242000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelors Degree required, or country equivalent
Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
Ability to work effectively in multinational/multicultural environment
Management skills
Sound basis of Scientific (Training/ Communications) knowledge
Expert knowledge of regulations, and experience with interpretation and application
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Established relationships with regulatory authorities
Demonstrated ability to lead, mentor, and develop others for future growth and development

Job Responsibility

Responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards
Leads, mentors, and develops others in service of Baxter's objectives in alignment with PSS’s hospital bed segment
Participates in strategic LRP and AOP for Hospital Beds
Responsible for all aspects of regulatory strategy for the PSS hospital bed product segment
Provides quarterly regulatory intelligence impact assessments for Batesville, IN site
Oversee Notified Body consolidation activities for the PSS hospital bed group
Lead regulatory efforts for consistent delivery of CCS business objectives
regulatory policy and implementation
and identification and prioritization of key opportunities and risks
Mentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Chief Auditor, Artificial Intelligence - Managing Director

At Citi, we value our talented employees and are committed to fostering professi...

Location

United States , New York

Salary:

250000.00 - 500000.00 USD / Year

Citi

Expiration Date

Until further notice

Requirements

A minimum of 15 years of diversified management experience in audit, technology, or a data-focused role
Proven experience working with AI/ML systems, including model development, validation, and auditing
Strong understanding of internal audit standards (e.g., IIA Standards) and risk management frameworks (e.g., COSO)
Deep knowledge of IT governance frameworks (e.g., COBIT, NIST) and key AI regulations (e.g., SR11-7, EU AI Act)
Familiarity with MLOps principles, cloud-based AI/ML platforms, and AI-specific security risks
Bachelor's degree in Computer Science, Data Science, Finance, or a related field
a Master's degree is preferred
Relevant certifications such as CISA, CIA, or CRISC are highly beneficial
AI-related certifications are a plus
Exceptional communication and interpersonal skills, with the ability to influence stakeholders at all levels

Job Responsibility

Architect a Pioneering Assurance Strategy
Lead High-Impact Audit Delivery
Drive Technological Transformation
Engage at the Highest Levels
Build and Develop Elite Teams

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages including planned time off (vacation), unplanned time off (sick leave), and paid holidays
discretionary and formulaic incentive and retention awards

Fulltime

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Regulatory Program Manager, Automation & Intelligence

As Block has scaled, so has the complexity of our regulatory environment. The Se...

Location

United States , Bay Area

Salary:

135800.00 - 245400.00 USD / Year

Cash App

Expiration Date

Until further notice

Requirements

8+ years of experience in program management, BizOps, regulatory operations, or a related field with a track record of driving process improvement and technology adoption in complex, cross-functional environments
Genuinely excited about AI and automation, with experience using AI assistants, workflow automation platforms, and LLM-powered tools
Experience leading change management and enablement initiatives in risk-sensitive environments
Analytically strong with program tracking data, remediation metrics, and building business cases
Strong EQ and ability to influence without authority
Experience in regulated industries (fintech, financial services, or similar) is a strong advantage
Familiarity with AML/BSA, CFPB supervision, or consent order management is highly desirable
Understands the stakes with direct visibility to Block's Steering Committee and Board of Directors

Job Responsibility

Champion AI & Automation Adoption
Identify & Build Automation Opportunities
Own the AI & Automation Roadmap
Drive Tool Optimisation
Translate AI for a Regulatory Audience
Build Scalable Frameworks
Measure What Matters
Cross-Functional Collaboration
Stay Ahead of the Curve
Roll Up Your Sleeves When It Counts

What we offer

Remote work
Medical insurance
Flexible time off
Retirement savings plans
Modern family planning

Fulltime

New

Executive Director, Facilities & Engineering

Location

United States , West Greenwich

Salary:

243724.00 - 329744.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of experience in an engineering discipline or related technical field OR Master's degree and 10 years of experience in an engineering discipline or related technical field OR Bachelor's degree and 12 years of experience in an engineering discipline or related technical field AND Minimum of 6 years of managerial experience directly leading people within a multi-tiered organization and/or leading teams, projects, programs, or resource allocation activities.

Job Responsibility

Lead the organization responsible for supporting GMP manufacturing operations (24x7x365) while optimizing asset lifecycle management across the site for biologics drug substance manufacturing, warehousing, central utilities, quality control laboratories, process development laboratories, and administrative facilities
Serve as a member of the ARI Site Leadership Team (SLT)
Serve as a member of the Global Engineering Leadership Team (ELT)
Align team vision, mission, strategic objectives, and goals with ARI site priorities and Global Engineering strategies
Foster and sustain a resilient safety culture across the organization
Ensure ongoing compliance and regulatory inspection readiness
Provide technical leadership in assessing emerging industry trends and partnering with vendors to identify innovative opportunities that improve reliability, efficiency, agility, and competitive differentiation
Build and maintain strong relationships with key site and network stakeholders
Ensure active engagement and participation of the ARI site within Amgen global networks
Participate in cross-functional daily management meetings within manufacturing operations, as required

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 where possible

Fulltime

New

Senior Director, Corporate Affairs, CV Communications

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Thousand Oaks

Salary:

198606.75 - 268703.25 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of communications or public relations experience
Master's degree and 9 years of communications or public relations experience
Bachelor's degree and 11 years of communications or public relations experience
5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
15 or more years of experience in communications, public relations, corporate affairs, or related fields
Deep understanding of the biotechnology, pharmaceutical, or healthcare industry paired with significant experience in cardiovascular disease communications
Demonstrated ability to develop and execute integrated communications strategies tied to clear business objectives, priority audiences, insights, KPIs, and measurable outcomes
Strong understanding of data, analytics, social listening, media intelligence, stakeholder insights, and measurement as core inputs to modern communications strategy
Practical experience using AI, digital platforms, analytics, and emerging technology to improve communications strategy, execution, efficiency, measurement, and impact
Strong executive presence and experience counseling senior leaders on business-critical communications opportunities and challenges

Job Responsibility

Lead global and U.S. communications for Amgen's cardiovascular portfolio, ensuring strategies are integrated, business-relevant, and aligned across key internal partners
Serve as a senior communications advisor and point of accountability to global and U.S. cardiovascular leadership teams
Develop and execute integrated communications strategies that support business objectives, strengthen Amgen's cardiovascular story, and engage priority audiences across global and U.S. channels
Lead communications for marketed products, future launch readiness activities, and stakeholder-facing campaigns
Partner across Corporate Affairs, including Advocacy, Enterprise Media, Internal Communications, Digital and Social, Policy Communications, and other key functions, as well as Investor Relations, Medical Affairs, Legal, Regulatory, Commercial, Government Affairs, and Value & Access, to deliver integrated strategies
Translate scientific, clinical, and business information into clear, credible, audience-relevant communications for patients, healthcare professionals, media, advocacy partners, internal audiences, and other stakeholders
Successfully use data, analytics, social listening, audience insights, and measurement to inform strategy, optimize execution, and demonstrate impact
Identify opportunities to responsibly use AI, digital tools, and emerging technology to improve planning, content development, stakeholder engagement, workflow efficiency, and measurement
Inspire and manage a high-performing team by setting clear priorities, supporting development, strengthening ways of working, and maintaining high standards
Anticipate and navigate emerging issues, new information, stakeholder dynamics, and rapid changes in the external environment

What we offer

A 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
Flexible work models where possible

Fulltime

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Director - Regulatory Intelligence

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