Director of Governance & Regulatory Affairs Job at Horizon Care and Education Group

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science
Master’s degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Job Responsibility

To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

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

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Director, European Regulatory and R&D Policy

In this vital role you will be responsible for creating an optimal regulatory en...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree in public health, life sciences, public policy, business administration and/or law degree
Demonstrable experience in policy development, analysis and influencing
Demonstrable experience in successfully executing global regulatory policy strategies
Experienced solutions-orientated self-starter

Job Responsibility

Leading the development and execution of strategic plans for each assigned policy area
Ensure that Amgen’s regulatory, safety and R&D policy positions are successfully represented to inform policy development and implementation
Provide internal stakeholders with strategic regulatory policy perspectives
Guide and advise senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Support the creating of necessary infrastructure/processes for developing the regulatory policy function
Influence the development and articulation of Amgen’s position on regulatory policies that impact Amgen’s business
Represent Amgen in interactions with external regulatory, political, policy and professional organisations in a manner that aligns with the “one Amgen’ approach”

What we offer

Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

Senior Director of Renewables, Campaigns

The Senior Director of Renewables, Campaigns will focus on advancing renewable e...

Location

United States

Salary:

140000.00 - 155000.00 USD / Year

Action for the Climate Emergency

Expiration Date

Until further notice

Requirements

10+ years of experience in the US power sector with expertise in renewable energy development, regulatory permitting, stakeholder engagement, policy advocacy, or public affairs within the energy industry
Bachelor's degree in a relevant field or equivalent experience
Demonstrated ability to design and execute campaigns, particularly at the state and local levels
Exceptional communication and writing skills
Proven experience building coalitions and engaging stakeholders across sectors
Demonstrated expertise in researching and analyzing policy and regulatory landscapes
Experience using renewable energy databases like Enverus, Curate, Landgate and AI tools
Strategic thinking capabilities with deep understanding of data use and ability to inspire and lead diverse teams
Strong project management skills
Self-starter who is proactive, flexible, and solutions-oriented

Job Responsibility

Support strategy development including drafting internal and external plans, memos and playbooks for accelerating deployment
Share and leverage subject matter expertise in community engagement, stakeholder relations, and project deployment across a variety of renewable energy technologies
Develop guides and collateral for engaging with local officials, stakeholders, and communities to promote renewable energy projects
Build and maintain relationships with renewable energy developers, policymakers, community leaders, funders, partners and other key stakeholders
Draft reports, memos, letters and other communications funders, developer clients, and other critical stakeholders as needed
Support advocacy efforts for policy and regulatory changes that streamline renewable energy deployment locally, at the state-level and nationally where applicable
Represent the organization at industry events, public hearings, and community forums to promote renewable energy initiatives
Support community engagement efforts with partners and other stakeholders, including town halls, community events, or other opportunities
Identify and analyze regulatory and policy opportunities to support renewable energy permitting and development-friendly ordinances
Conduct research on advocacy strategies, regulatory barriers, and best practices to inform campaign and outreach efforts

What we offer

Medical
Dental
Vision
403b retirement savings plan
Vacation
Sabbatical
Paid Parental Leave
2 Floating Holidays
2 Community Service Floating Holidays
Sick time

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 Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...

Location

United States , Washington, DC

Salary:

137846.78 - 241870.90 USD / Year

Adtalem Global Education

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, Master's Degree preferred
Minimum 10 years experience in a heavily regulated environment
preferably within post-secondary education required
Title IV compliance experience preferred
At least 5 years of supervisory experience
Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
Strong interpersonal, organizational, writing, editing, and computer skills are required
Strong understanding of federal Title IV regulations

Job Responsibility

Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues
Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
Recommends business practice changes to improve compliance with higher education laws and regulations
Ensures that corrections in the areas of non-compliance are made timely and accurately
In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements
Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
Utilizing both internal and external resources, supports efforts to influence federal and state regulation development

What we offer

Health, dental, vision, life and disability insurance
401k Retirement Program + 6% employer match
Participation in Adtalem’s Flexible Time Off (FTO) Policy
12 Paid Holidays
Eligible to participate in an annual incentive program

Fulltime

Health Policy & Reimbursement Executive Director

In this vital role the Health Policy & Reimbursement Executive Director will lea...

Location

United States , Washington D.C.

Salary:

281425.00 - 325550.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree & 6 years of health policy or reimbursement experience
Master’s degree & 10 years of health policy or reimbursement experience
Bachelor’s degree & 12 years of health policy or reimbursement experience
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Lead development and implementation of reimbursement strategies for federal (US) payer issues across multiple therapeutic areas and the company’s biosimilar portfolio
Work cross-functionally to help identify and resolve barriers to entry for pipeline products/ therapies and provide broad reimbursement-related advice for inline products, including mitigation strategies in response to proposals that would negatively affect access of Amgen therapies for patients
Manage broader health policy efforts including reviewing and analyzing complex policy proposals including regulatory proposals and legislative text, and promptly and concisely communicating impact of these proposals to key internal audiences (government affairs, commercial, regulatory, clinical, and senior executives)
Collaborate with government affairs staff to ensure alignment of strategy, talking points and messaging to constituents (elected officials/leaders, agencies, third parties, etc.)
Play a key role in health policy engagement with major trade associations on corporate policy priorities which include Amgen specific priorities as well as industry-wide priorities including, but not limited to, Federal drug pricing policy
Conduct research and integrate clinical, market and payer data to inform engagement on reimbursement objectives
Regularly update via written and oral communications to senior executives and other key partners on various reimbursement and US health policy topics

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 Director Regulatory Affairs

The Senior Director of Regulatory Affairs is responsible for assuring that all d...

Location

United States , Columbia

Salary:

137846.78 - 241870.90 USD / Year

Adtalem Global Education

Expiration Date

Until further notice

Requirements

Bachelor's Degree required, Master's Degree preferred
Minimum 10 years experience in a heavily regulated environment
preferably within post-secondary education required
Title IV compliance experience preferred
At least 5 years of supervisory experience
Must be familiar with the standards and requirements of the U.S. Department of Education, multiple state authorizing agencies and programmatic accreditors
Must possess strong critical thinking skills to decipher regulatory requirements that may not be explicit
Demonstrated ability to establish and develop positive relationships with senior leaders and external agencies
Strong interpersonal, organizational, writing, editing, and computer skills are required
Strong understanding of federal Title IV regulations

Job Responsibility

Leads and motivates the Regulatory Research, Compliance Review, Regulatory Strategy and Reporting teams of Regulatory Affairs colleagues, achieving strategic and compliance objectives of the organization
Collaborates with institution and business leaders, as well as peers in Regulatory Affairs, Internal Audit and Legal, to drive continual process and quality improvement
Monitors operations in all departments/functions to ensure compliance with federal and state/provincial higher education-related laws and regulations and organizational and divisional policies
Establishes working relationships with operating managers to assess the viability of their compliance functions, and educate operating units as to the essential components of a strong compliance program
Coordinates the compilation and synthesis of reporting for the quarterly Regulatory Compliance and Quality Assurance reviews with each of the institutions
Recommends business practice changes to improve compliance with higher education laws and regulations
Ensures that corrections in the areas of non-compliance are made timely and accurately
In coordination with the appropriate organization managers, reviews proposed process changes (including system requirements) to ensure they are in compliance with higher education-related federal and state/provincial laws and regulations and corporate and divisional requirements in the areas of academics, career services, enrollment management, state and provincial licensing, student finance, and student services
Immediately reports areas of concern to the VP, Sr. Associate General Counsel and develops correction action plans and appropriate training requirements
Utilizing both internal and external resources, supports efforts to influence federal and state regulation development. Serves as a resource for Adtalem’s Government Relations team on legislative matters related to institutions of higher education

What we offer

Health, dental, vision, life and disability insurance
401k Retirement Program + 6% employer match
Participation in Adtalem’s Flexible Time Off (FTO) Policy
12 Paid Holidays
Eligible to participate in an annual incentive program

Fulltime

Director of Governance & Regulatory Affairs

Horizon Care and Education Group

Location:
United Kingdom

Category:
Public Sector

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 18, 2026

Expiration:
January 30, 2026

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