Director, Government Affairs Job at Microsoft Corporation (Seoul)

Director of Government & Customer Relations

Responsible for the local and regional government affairs and customer relations...

Location

United States , Cleveland

Salary:

147521.00 - 191777.00 USD / Year

Engage Cleveland

Expiration Date

Until further notice

Requirements

Candidate must possess a bachelor’s degree preferably in Political Science, Public Policy, Public Relations, Communications, Public Administration or a closely related field
Candidate must possess ten (10) years of experience in government affairs and/or community or public relations
Experience must include five (5) years of supervising, managing, and/or leading people, projects, and/or processes
Candidate must possess a valid driver’s license with a driving record in accordance with the Sewer District’s acceptable guidelines
Candidate must have the ability to fully learn the work and strategic direction of the Sewer District and communicate it to a variety of audiences
Candidate must possess effective written and verbal communication, organizational skills and decision-making abilities
Candidate must possess strong team leadership and people management skills
Candidate must possess the ability to effectively plan, coordinate, establish and maintain effective working relationships and prioritize workloads based on available resources
Candidate must possess negotiation and conflict resolution skills to address issues and opportunities for improvement

Job Responsibility

Develops and oversees the execution of strategic goals for the government affairs and customer relations functions based on the objectives of the Sewer District
Builds and maintains local and regional relationships including elected officials, government administrations, community and business stakeholders to foster two-way communications
Represents the Sewer District at events with local and regional government agencies, community stakeholders, local and national organizations
Advises all departments regarding the Sewer District’s interest in local government affairs
Facilitates internal communications between relevant departments to maintain coordinated Sewer District-wide government affairs activities
Oversees the department’s workforce development programs and student initiatives, including all associated contracts
Leads and coaches program managers as needed
Oversees customer relations communication channels for effective, seamless and targeted approach to customer contact at all levels
Monitors customer relations results and metrics
Leads, directs, supervises and coaches the department managers and staff to achieve performance goals

What we offer

Health Insurance Coverage
Various Retirement Planning Options (Ohio Public Employee Retirement System and Deferred Compensation Plans)
Flexible Spending Accounts
Employee Assistance Program
Free Parking at our facilities
Corporate Discounts
active Health & Wellness Program that promotes a life/work balance

Fulltime

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

Government Affairs Director, Infrastructure

Microsoft’s mission is to empower every person and every organization on the pla...

Location

United States , Multiple Locations

Salary:

132200.00 - 258000.00 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 6+ years work experience in government affairs, corporate affairs, public policy, government, or related area
Experience in advocacy in technology, real estate development, or government space and experience in developing and implementing strategic plans to drive policy and development objectives

Job Responsibility

Promote Microsoft as a trusted local and worldwide leader in providing AI and cloud services and responsibly developing the infrastructure to host those services
Develop and maintain strategic relationships with state and local government officials in your regions
Advocate for public policy positions conducive to data center development including, but not limited to issues of energy, taxation, development, workforce and sustainability
Work closely with Microsoft’s Public Affairs and TechSpark teams to provide communications and programming in communities surrounding data center development
Work closely with data center development teams and their executive leadership to support their work with local government and regulators in key markets
Represent Microsoft interests with governments, business and community organizations to enhance Microsoft’s state and local presence
In consultation with Microsoft’s State Government Affairs team, coordinate government affairs consultants / lobbyists activities in furtherance of Microsoft’s policy agenda in select geographies
Represent Microsoft at external events, meetings and conferences when needed
Identify opportunities for collaboration with other organizations on issues of mutual interest
Develop coalitions to support Microsoft’s policy agenda as appropriate

Fulltime

Account Director

CLYDE is a fast-paced, integrated communications and public affairs agency. We a...

Location

United States , Washington, DC

Salary:

88300.00 - 127200.00 USD / Year

CLYDE

Expiration Date

Until further notice

Requirements

6-8 years of integrated communications experience
6-8 years of communications or public affairs experience at a communications agency, think tank, in-house, Capitol Hill, or other government agency
Direct supervisor for 1-3 team members
Strongly focused on self-guided development
Has a strong understanding of client onboarding materials and can set up accounts effectively
Fluency in contemporary digital channel strategies and analytics
Has excellent writing skills
master of AP style
Is able to communicate around sensitive/challenging client issues
Sees risks/threats before clients do, and can sensitively raise them to clients with proposed solutions

Job Responsibility

Play a critical role on client teams, building relationships with clients, serving as a go-to resource for clients, and providing strategic communications advice and direction to achieve client goals
Collaborate closely with client and internal teams to develop sophisticated and creative integrated communications campaigns—and be confident in shifting strategies to address emerging trends, threats, and opportunities
Ensure client outcomes are achieved
Ensure all client deadlines are met and the quality of work is high while also remaining on budget
Oversee financial aspects of the client work, including SOW development, monthly reporting, monthly billing, client profitability, and team member utilization
Confident standing up new client accounts, including developing the resources and tools needed to execute against SOW and achieve client goals
Present clearly and persuasively to clients
Direct business development process for potential clients
Manage one or more direct reports and guide their professional development
Support CLYDE initiatives

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