Director - Regulatory Intelligence Job at Waystone Governance Ltd.

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Director - Regulatory Intelligence

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

Location

Ireland , Cashel; Dublin; London; Leeds; Luxembourg

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, 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

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

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expert knowledge of drug safety regulations and pharmacovigilance processes
Strong analytical and problem-solving abilities
Excellent communication and presentation skills
Superior organizational and time management capabilities
Proficiency with pharmacovigilance systems and databases
Proven experience in safety case management and regulatory reporting
Proficiency with safety databases and data analysis
Strong knowledge of ICH guidelines and regional requirements
Demonstrated mentoring abilities and process improvement skills
Experience in pharmaceutical or healthcare environments

Job Responsibility

Maintain expert-level knowledge of safety profiles, labeling, and global regulations
Lead development of project-specific procedures and workflows
Provide technical guidance to junior team members
Prepare for and participate in audits and inspections
Analyze metrics and drive continuous improvement
Collaborate with cross-functional teams on safety deliverables
Identify risks and recommend mitigation strategies
Ensure compliant documentation and archiving
Lead project management including safety procedure development and database setup
Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)

Director, Operational Quality

We manufacture and supply reliable, high-quality medicines and vaccines to meet ...

Location

United States , Collegeville, Pennsylvania

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s Degree
7+ years of pharmaceutical industry experience
Experience in at least one of the areas of Quality Assurance/Operations, Production, or Engineering
Project management experience
Team leadership experience

Job Responsibility

Provide leadership for securing new products from business partners in GSK and outside GSK
Manage development and performance objectives while providing coaching, mentoring, and feedback on a regular basis to a team of Quality professionals
Establish clear accountabilities regarding product quality, employee safety, Clinical Good Manufacturing Practices (cGMP) compliance, OSHA compliance, and consistently achieving production schedules to meet market demand
Guide, support, train and assess third party sites in regulatory inspections, including response writing
Support the efforts to positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly collated, analyzed, and distributed for incorporation in local action plans
Lead site GMP compliance activities including but not limited to self-inspection, internal audit, compliance metrics, Quality Management Systems (QMS) implementation, Quality Regulatory Intelligence, Quality Risk Model, Drug Enforcement Administration (DEA) compliance, and Corrective and Preventive Actions (CAPA) verification
Embed industry manufacturing tools and techniques to identify, manage, and escalate problems and develop solutions
Mobilize and co-ordinate appropriate resources to address any significant product quality or regulatory incident
Achieve objectives and work with a direct and indirect multi-functional team of Commercial, Business development, Regulatory, Technical and Supply within the region and the wider GSK global team
Influence, build good relationships with key individuals, internally and externally, with pressure and recourse to contractual requirements

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

Fulltime

AI Government Affairs Director

You will report to the Senior Director of Public Policy & Government Affairs (PP...

Location

United States , Washington

Salary:

125900.00 - 249900.00 USD / Year

Pepsico

Expiration Date

Until further notice

Requirements

Bachelor’s Degree
7+ years in government affairs, public policy, or corporate public
Experience with the varied US public policy processes at the state and federal levels, and familiarity with international regulatory issues related to artificial intelligence
Strong verbal and written communications skills, including the ability to communicate with internal and external audiences
Highly proactive and able to navigate ambiguity and complexity while developing successful solutions
Strong relationship building skills and ability to thrive within a rapidly changing environment

Job Responsibility

Monitor, prioritize, and advise on public policy developments impacting PepsiCo, ensuring senior leadership is informed and prepared
Develop and implement, with the Senior Director, comprehensive advocacy strategies and campaigns on artificial intelligence and technology related policies
Lead planning and staffing of senior level executives for AI advocacy and thought leadership initiatives in DC
Represent PepsiCo externally on priority issues before policymakers, trade associations, and key stakeholders
Build and maintain a strong network of relationships with lawmakers, staff, industry representatives, and other stakeholders
Coordinate with internal teams—including strategy and transformation, legal and communications—to align policy strategies with business objectives
Carry out strategies and actions with the highest level of integrity and ethics

What we offer

Bonus based on performance and eligibility target payout is 25% of annual salary paid out annually and an additional target payout of 10% of annual salary is paid out over 3 years following the end of the performance period
Long term incentive equity may be awarded based on eligibility and performance
Paid time off subject to eligibility, including paid parental leave, vacation, sick, and bereavement
Medical, Dental, Vision, Disability, Health, and Dependent Care Reimbursement Accounts, Employee Assistance Program (EAP), Insurance (Accident, Group Legal, Life), Defined Contribution Retirement Plan

Senior Director, Intellectual Policy & Strategy

Microsoft’s Intellectual Property Group seeks a Senior Director, Intellectual Po...

Location

United States , Redmond

Salary:

160700.00 - 284400.00 USD / Year

Microsoft Corporation

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Public Policy, Public Administration, Political Science, Business Administration, Technology, Law, Liberal Arts, Engineering, or related field AND 8+ years work experience in government affairs, corporate affairs, public policy, government, or related area
OR equivalent experience
8+ years experience in developing and managing strategic relationships to advocate and influence public, regulatory, and technology policy priorities
8+ years experience influencing, developing, or supporting public policy or political campaigns
Proven impact in technology policy roles, with a history of contributing to advocacy efforts or policy initiatives in intellectual property and artificial intelligence
Proficiency in analyzing and interpreting regulatory processes, with the ability to align policy insights with strategic product and business goals
Expertise with copyright and open data initiatives
Proficient problem-solving skills, demonstrating adaptability in navigating shifting policy landscapes and emerging challenges
Passion for technology policy, with experience participating in technology communities, standards bodies, and open-source communities

Job Responsibility

Develop and execute Microsoft’s global intellectual property policy agenda, advocating for initiatives that enable thoughtful AI diffusion
Collaborate with internal teams and external stakeholders to craft and deliver materials that address emerging regulatory challenges
Analyze complex policy landscapes, contribute insights to create impactful position papers, policy briefings, and advocacy strategies within dynamic regulatory and political environments
Build and strengthen relationships with government policymakers, industry influencers, civil society, researchers and academic partners to share Microsoft’s perspective in the policy space and drive collaborative outcomes
Coordinate external engagements, convenings, and industry reports in an effort to shape the policy conversation in dynamic regulatory and political environments

Fulltime

Director, Product Development

We're looking for a Director, Product Development to build amazing experiences t...

Location

Salary:

100000.00 - 145000.00 EUR / Year

KOR Financial

Expiration Date

Until further notice

Requirements

A Bachelor's degree in Finance, Economics, Law, Business, or a related field
A minimum of 10+ years of experience in the financial services industry, with significant experience at a large sell-side investment bank
Deep subject matter expertise in major global derivatives regulations (e.g., Dodd-Frank, EMIR, MiFID II/MiFIR, and rules from Canadian, Australian, and Singaporean regulators)
Proven track record of leading large-scale, cross-functional regulatory change or compliance programs
Demonstrated experience in gathering and writing business requirements and overseeing technology implementation programs in a financial services context
Exceptional analytical and problem-solving skills, with a proficiency in leveraging data analysis tools to inform strategic decisions
Strong understanding of relational databases and the ability to use SQL for complex data investigation and validation
Outstanding communication and presentation skills, with proven experience influencing and advising senior business leaders

Job Responsibility

Product Line Ownership: Serve as the ultimate owner and senior subject matter expert for regulatory intelligence and change management for a designated set services
Strategic Leadership & Advisory: Lead the strategic monitoring and interpretation of the global derivatives regulatory landscape, focusing on key regulators such as the CFTC, SEC, ESMA (EMIR), UK FCA (MiFID II), Canadian regulators, ASIC, and MAS
Program Oversight: Own and govern the end-to-end software development lifecycle for your product area
Senior Stakeholder Management: Drive engagement with senior leaders across Technology, Operations, Legal, and Compliance
Drive Technology & Business Solutions: Lead the translation of complex regulatory text into clear, actionable business and functional requirements
Governance and Reporting: Establish and maintain a robust governance framework for regulatory change within your product area
Team Leadership and Mentorship: Provide guidance, mentorship, and development to junior members of the product development team

What we offer

Culture of trust, empowerment, and constructive feedback
Competitive salary, great hard and tools, and benefits (employees only)
Flexible working times
Fully remote
A span of control that matches your ambitions and skills
health coverage
flexible paid time off
remote-work perks that support your well-being and work-life balance

Fulltime

Director - Regulatory Intelligence

Waystone Governance Ltd.

Location:
United Kingdom

Category:
Legal

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 22, 2026

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Job Description:

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