Government And Regulatory Affairs Associate Job at EDP (Multiple cities)

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

Federal Affairs Lead

Archer Aviation is hiring a Federal Affairs Lead to strengthen our efforts in sh...

Location

United States , Washington

Salary:

115000.00 - 154000.00 USD / Year

Archer Aviation

Expiration Date

Until further notice

Requirements

At least 3 years of relevant policy, regulatory, or government affairs experience
Bachelor’s degree in public policy, political science, or related field (Hill experience is preferred)
Familiarity with federal transportation, aerospace, or emerging technology policy
Strong written and verbal communication
being able to explain technical concepts to non-technical audiences
Proven ability to build and maintain relationships with government official’s staff, stakeholders and advocacy organizations
Skilled at analyzing policy documents and making clear, actionable recommendations

Job Responsibility

Support Archer’s federal government affairs strategy to advance policies that enable the growth of the AAM industry
Build and maintain strong relationships with key Congressional offices, federal agencies, and industry associations to advocate for Archer’s priorities
Monitor and analyze policy and regulatory developments
provide timely insights and recommendations to internal teams
Represent Archer at relevant D.C. events, conferences, and member organization meetings, ensuring the company’s voice is influential in shaping the future of AAM
Develop clear and compelling presentations, briefings, and advocacy materials for policymakers and regulators
Collaborate with internal teams to align policy strategy with business objectives and foster a results driven environment

Government Relations Specialist

Corporate Tools is hiring a Government Relations Specialist. You will be a tradi...

Location

United States

Salary:

80000.00 - 90000.00 USD / Year

Corporate Tools

Expiration Date

Until further notice

Requirements

Bachelor's degree (highly preferred)
Strong verbal and written communication skills and ability to adapt communication style to different audiences
At least 2- 4 years of previous, demonstrated experience in a government relations role
Knowledge and understanding of the legislative, regulatory, and policy making processes
An ability to develop and maintain political and key stakeholder relationships
Strong interpersonal skills with the ability to positively interact with diverse political bodies, build relationships, and resolve conflicts diplomatically
Excellent legislative research, writing, research and analysis skills
Ability to travel 25% - 35%, on average, based on the needs of the company

Job Responsibility

Work with Government Relations team to develop and drive advocacy and outreach strategies before federal and state legislative bodies and regulatory agencies on key business issues
Engage policymakers and other policy stakeholders to protect the company’s interests and public policy goals
Collaborate with stakeholders across the company to drive the development of public policy positions
Conduct research and analysis on trending legislative, regulatory, and public policy issues
Assist with building and maintaining relationships with federal and state regulatory agencies and legislative bodies (state legislative bodies, Congress, administration officials)
Contribute to team projects, deliverables, and presentations on a diverse range of legislative and policy topics
Develop briefing materials for internal and external stakeholders on legislative and regulatory issues
Engage with industry associations and third-party coalitions on relevant issues
Travel (35% - 40%) to represent the company before legislative bodies and industry events

What we offer

100% employer-paid medical, dental and vision for employees
Annual review with raise option
22 days Paid Time Off accrued annually, and 4 holidays
After 3 years, PTO increases to 29 days. Employees transition to flexible time off after 5 years with the company—not accrued, not capped, take time off when you want
The 4 holidays are: New Year’s Day, Fourth of July, Thanksgiving, and Christmas Day
Paid Parental Leave
Up to 6% company matching 401(k) with no vesting period
Quarterly allowance
Use to make your remote work set up more comfortable, for continuing education classes, a plant for your desk, coffee for your coworker, a massage for yourself... really, whatever
Open concept office with friendly coworkers

Fulltime

Senior Manager, Government & Regulatory Affairs

GEICO is seeking an accomplished government relations professional to join our t...

Location

United States , Sacramento

Salary:

158875.00 - 248050.00 USD / Year

Geico

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) degree from an accredited law school and admission to practice law in at least one U.S. jurisdiction highly preferred
Minimum 10 years’ relevant government affairs experience with knowledge of insurance regulation, regulatory law, or related public policy fields, preferably within property and casualty insurance
knowledge of auto insurance a plus
Proven experience, with a track record of successfully developing and implementing regulatory and legislative strategies
Deep knowledge of U.S. insurance regulatory systems, including state insurance departments and the National Association of Insurance Commissioners
Strong analytical skills, with the ability to translate complex regulatory developments into actionable business strategies
Strong verbal and written communication and presentation skills tailored to different audiences
Exceptional communication, negotiation, and interpersonal skills, with a collaborative approach to working within cross-functional teams
Ability to balance independent legal judgment with teamwork and enterprise-wide policy development processes
Ability to articulate GEICO’s positions in an impactful and persuasive manner to decision makers and industry leaders and to offer strategic advice on complex legislative and regulatory issues to business professionals

Job Responsibility

Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO’s positions in assigned states. Develop comprehensive strategic plans to facilitate effective engagement with legislative and regulatory stakeholders to achieve GEICO’s business objectives
Regulatory & Legislative Analysis: Review and evaluate impactful insurance regulatory/ legislative proposals, working in close collaboration with relevant Government & Regulatory Affairs colleagues and other internal stakeholders. Ensure that GEICO's business units and corporate functions remain informed about critical and emerging issues
Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making
Strategic Support: Work with the Director of Public Policy and business stakeholders to develop policy positions, strategy, responses/draft language
prepare for legislative and regulatory interactions
and support company’s strategic initiatives
Coalition Building: Support the strategic implementation of GEICO’s key public priorities through coalition building and coordination of external resources. Maximize outside firms and association memberships to successfully advocate GEICO’s priorities. Develop and execute effective and efficient political contributions strategies in assigned states, in consultation with business, to enhance GEICO’s policy agenda
Additional Duties: Assume other regulatory or legislative responsibilities as priorities evolve

What we offer

Comprehensive Total Rewards program that offers personalized coverage tailor-made for you and your family’s overall well-being
Financial benefits including market-competitive compensation
a 401K savings plan vested from day one that offers a 6% match
performance and recognition-based incentives
and tuition assistance
Access to additional benefits like mental healthcare as well as fertility and adoption assistance
Supports flexibility- We provide workplace flexibility as well as our GEICO Flex program, which offers the ability to work from anywhere in the US for up to four weeks per year

Fulltime

Public Policy Manager, Japan

Meta is seeking an experienced Public Policy Manager to contribute to Meta's pol...

Location

Japan , Tokyo

Salary:

Not provided

Iberia Public Policy and Government Associate Manager

Public Policy and Government Affairs (PPGA) has a significant impact on PepsiCo’...

Location

Spain , Madrid

Salary:

Not provided

Pepsico

Expiration Date

Until further notice

Requirements

Min. 10 years of work experience in FMCG sector, PPGA agencies, trade Associations on government affairs, corporate affairs
Deep understanding of global and local regulatory issues and general knowledge of food and beverage sector
Good understanding of the Iberian government system and an existing network of key stakeholders
Ability to manage trade bodies agendas with little oversight
Sound judgement on political/external developments and the ability to analyse and assess their importance to PepsiCo
Strategic approach to business-critical public policy challenges
An ability to operate and navigate in environments, and on issues, with significant complexity and ambiguity
Ability to manage multiple inputs from a wide group of stakeholders and then incorporating them into a recommendation with a commercial lens applied
Ability to think broadly and influence multiple stakeholders with a track record of conveying and implementing issue analyses, and engagement plans
Highly analytical, motivated, decisive manager with excellent communication and persuasion skills

Job Responsibility

POSITION DEVELOPMENT: Strategically monitor policy developments, and own public policy position development on a range of public policy issues (eg. taxation, market restrictions, ultra processed food, unfair trading practices, packaging and climate regulations)
EXTERNAL ENGAGEMENT: Support execution of the day-to-day PPGA work programme, engaging with external public affairs consultancy and trade associations (Anfabra, Snacks association, Gazpacho association, DRS association, FIAB)
Attend sessions of ad hoc working groups/bodies in trade associations to monitor policy developments influence/advocate PEP positions and manage day to day relationship
Coordinate PEP representation in technical working groups within the DRS trade association to secure cost-effective DRS (deposit return scheme) vs EPR agenda
Support external engagement programme (prioritized by anticipated impact) collaborating with a range of stakeholders including policymakers, politicians, NGOs, thinktanks, peer companies etc
EXECUTIVE BRIEFINGS AND REPORTS: Write briefing documents on key PPGA issues for internal stakeholders (up to the Iberian and senior executive team) to inform and guide engagement with government officials and other key global stakeholders AND Manage PPGA reporting (monthly and quarterly) to sector and global, being the liaison with Center of Excellence of PPGA and social impact
EXTERNAL REPUTATION OUTLETS: Gather corporate data to complete diverse reports (such as Merco survey, trade associations surveys, costumer detail on PEP+)
Coordinate and prepare submissions for awards (AECOC
InnovaCcion Promarca, Corresponsables, etc)
RISK MANAGEMENT: Evaluate and act as a gatekeeper for the approval of 1) external marketing activities (including advertisements, social media etc.) regarding PepsiCo’s policies and external commitments and 2) all company donation requests with regards to PepsiCo corporate priorities and Winning with pep+ principles

Senior Manager Government Affairs

We are seeking a Senior Manager to join our Global Government Affairs team Schaf...

Location

Switzerland , Schaffhausen

Salary:

Not provided

Aptiv plc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in finance, Business Administration, Economics, or a related analytical discipline or Advanced degree preferred, such as an MBA or a Master’s in Public Policy, Taxation, or International Business
Strong proficiency in German and English is essential
Minimum 6 years of relevant professional experience in government affairs, finance, or related roles within a multinational corporation, advisory firm, or industry association
Demonstrated success in identifying and securing government grants, incentives, or public funding programs across multiple jurisdictions
Proven financial expertise, including financial modeling, and performance reporting to support strategic decision-making
Strong understanding of global policy, trade, and regulatory environments, with the ability to translate legislative developments into financial and strategic implications
Experience managing complex, cross-functional projects involving finance, policy, and operations, with a track record of delivering results under tight timelines
Exceptional communication skills, capable of presenting complex financial and policy insights clearly to senior leadership and diverse stakeholders
Advanced proficiency in Microsoft Excel (financial modeling), PowerPoint (executive presentations), and Word (documentation and reporting)
Comfortable engaging with external stakeholders, including government agencies and industry bodies

Job Responsibility

Identify and secure global grants, incentives, and funding opportunities to support corporate investments, R&D, sustainability, and strategic initiatives across multiple jurisdictions
Develop and execute strategies for government engagement that align with corporate objectives and maximize financial benefits through public programs and incentives
Lead financial analysis and modeling to evaluate the impact of policy changes, trade regulations, and incentive programs on business performance and investment decisions
Partner with cross-functional teams (Finance, Tax, Legal, Operations) to integrate government affairs strategies into financial planning and capital allocation
Manage global tracking and reporting of grants, subsidies, and incentive commitments, ensuring compliance and transparency
Build relationships with government agencies and industry bodies to advocate favorable policies and access funding opportunities
Prepare high-impact business cases and executive presentations demonstrating the financial and strategic value of government programs and regulatory developments
Monitor global legislative and regulatory trends to anticipate opportunities and risks, providing actionable insights to senior leadership
Coordinate with regional teams to ensure consistent execution of incentive strategies and alignment with corporate priorities
Drive continuous improvement in processes for identifying, applying for, and managing government incentives globally

What we offer

You can grow at Aptiv. Aptiv provides an inclusive work environment where all individuals can grow and develop, regardless of gender, ethnicity or beliefs
You can have an impact. Safety is a core Aptiv value
we want a safer world for us and our children, one with: Zero fatalities, Zero injuries, Zero accidents

Fulltime

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Government And Regulatory Affairs Associate

Job Responsibility

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