Title: Director, Regulatory Affairs CMC Location: United States Job Description: For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is a senior-level contractor role responsible for defining and executing global CMC regulatory strategies across Dyne’s development programs, from early-stage development through commercialization and post-approval lifecycle management. This individual will serve as a strategic leader and subject matter expert (SME), ensuring high-quality, compliant, and globally aligned CMC regulatory submissions. The role will partner closely with Manufacturing, Quality, Clinical Operations, and Program Teams to support clinical registration, commercial readiness, and ongoing regulatory compliance. The position requires a highly experienced regulatory professional capable of operating independently, influencing cross-functional stakeholders, and driving complex regulatory strategies while meeting critical timelines in a fast-paced, dynamic biotech environment. Primary Responsibilities Include: - Lead and execute global CMC regulatory strategies across all phases of development, including IND, IMPD, BLA/MAA, and post-approval lifecycle activities - Provide strategic regulatory guidance to Manufacturing and Quality teams to ensure global compliance and readiness for clinical and commercial supply - Oversee the planning, development, and delivery of CMC sections for global regulatory submissions, including responses to Health Authority (HA) questions - Manage regulatory activities related to clinical and commercial manufacturing changes, ensuring alignment with global requirements - Ensure CMC regulatory content aligns with evolving regulatory expectations, guidance, and policy trends across regions - Coordinate global submissions, product registration maintenance, and change control activities throughout the product lifecycle - Partner cross-functionally with Manufacturing, Quality, Clinical Operations, and Program Teams to deliver key regulatory milestones - Proactively identify regulatory risks and develop mitigation strategies to support program success - Leverage deep regulatory expertise to anticipate challenges and drive effective, forward-looking solutions - Contribute to organizational regulatory knowledge by sharing insights, lessons learned, and best practices Education and Skills Requirements: - Bachelor’s degree in Life Sciences or a related scientific discipline required; advanced degree (MS/PhD) preferred - Minimum of 10+ years of experience in biotechnology or pharmaceutical industry, including at least 7+ years in Regulatory Affairs with strong focus on CMC - Demonstrated experience leading CMC sections of global regulatory submissions, including biologics marketing applications (BLA/MAA) - Strong experience supporting global regulatory filings and health authority interactions (e.g., FDA, EMA, and other international agencies) - Deep understanding of CMC regulatory requirements across clinical development, commercialization, and lifecycle management - Strong working knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks - Experience with EU and international regulatory requirements for both clinical and commercial programs is preferred - Extensive experience with CTD structure, content, and global submission requirements - Proven ability to independently manage multiple complex regulatory programs in a fast-paced environment - Strong strategic thinking and problem-solving skills, with the ability to balance scientific, operational, and regulatory considerations - Excellent written and verbal communication skills, including regulatory writing and executive-level communication - Demonstrated ability to influence cross-functional stakeholders and senior leadership without direct authority - High level of attention to detail with strong commitment to quality and compliance - Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities - Ability to work independently and operate in a highly autonomous manner with minimal oversight - Candidates must demonstrate recent, hands-on experience supporting CMC regulatory activities within regulated life sciences environments Engagement Details: - Contract Duration: 12-month contract with potential for extension based on performance and business needs - Engagement Type: Full-time contractor (FTE-equivalent) - Time Zone Required: EST hours - Location / Delivery Model: Primarily remote, with potential for occasional on-site presence in Waltham, MA as needed - Travel: May be required for end-user training and key project phases We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Title: GRC Analyst Location: United States Job Description: About Zone & Co: Zone & Co is on a mission to empower finance professionals to drive strategic growth through seamless, intelligent operations. We build cloud-native software solutions on Oracle NetSuite, automating complex financial processes like billing, accounts payable, reporting, and reconciliation. Our vision is to unlock the full strategic potential of finance by infusing the ERP with the intelligence and automation needed for truly transformative operations. Join our rapidly growing team as we redefine financial efficiency for scaling businesses worldwide. The Role: We are seeking a meticulous and proactive Security and Privacy Compliance Analyst to help safeguard our organization and our customers' data. Reporting directly to the Director of IT, Security and Compliance, you will play a critical role in maturing our governance, risk, and compliance (GRC) programs. In this position, you will bridge the gap between technical security controls and regulatory requirements, ensuring that Zone & Co's rapidly expanding suite of financial software maintains the highest standards of data protection and privacy. This role requires a strong foundational knowledge of major security frameworks and privacy regulations, a keen eye for detail in auditing internal processes, and the ability to clearly communicate compliance postures to both internal engineering teams and enterprise customers. Essential Job Functions: - Compliance Framework Governance: Lead the management and continuous scaling of Zone & Co’s core security compliance frameworks, specifically SOC 2 Type II and ISO 27001. - Privacy Operations Leadership: Govern global data privacy operations to ensure strict, ongoing alignment with GDPR, CCPA/CPRA, and other emerging data protection laws. - Customer Trust & Revenue Enablement: Serve as the primary security liaison for enterprise customers, directly supporting the sales cycle by demonstrating and communicating a robust, mature security posture. - Risk & Audit Management: Manage the organization's internal audit program and oversee the third-party vendor risk lifecycle to proactively identify and mitigate vulnerabilities. Responsibilities, Duties, and Tasks: - Audit Coordination: Coordinate evidence collection, manage project timelines, and partner directly with external auditors during annual compliance assessments. - Privacy Assessments: Conduct Data Privacy Impact Assessments (DPIAs) for new products and process Data Subject Access Requests (DSARs) within mandated SLAs. - Questionnaires & Trust Center: Accurately and efficiently complete incoming vendor security questionnaires from prospects and maintain up-to-date documentation in our customer-facing Trust Center. - Internal Control Testing: Design and execute internal audits to test whether technical and administrative controls are operating effectively. Track control gaps and drive engineering/IT remediation efforts. - Vendor Risk Reviews: Evaluate the security and privacy postures of prospective and existing third-party vendors and sub-processors through comprehensive risk assessments. - Policy & Training Development: Draft, update, and publish internal security policies, standard operating procedures (SOPs), and incident response plans. Develop and administer engaging company-wide security and privacy awareness training. What You'll Bring (Qualifications and Experience): - Experience: 3+ years of direct experience in IT Audit, Information Security, Privacy Operations, or GRC (Governance, Risk, and Compliance), preferably within a B2B SaaS, FinTech, or cloud technology environment. - Deep Domain Expertise: Hands-on experience working with established compliance frameworks (SOC 2, ISO 27001) and navigating global privacy legislation (GDPR, CCPA). - SaaS/Cloud Acumen: A solid understanding of cloud computing architectures (AWS, Azure, GCP) and enterprise software environments. Familiarity with ERP systems (like NetSuite) is a strong plus. - Analytical & Problem-Solving Skills: Proven ability to translate complex regulatory requirements into actionable, practical controls for IT and engineering teams without stifling innovation. - Exceptional Communication: Outstanding written and verbal communication skills. You must be able to write clear policies, translate technical risks for business leaders, and confidently answer complex customer security questions. - Education & Certifications: Bachelor’s degree in Information Systems, Cybersecurity, Business, or a related field. Relevant industry certifications such as CISA, CISM, CIPP/E, CIPP/US, or Security+ are highly preferred. Benefits At Zone, our benefits are designed to enrich your life beyond the workplace. Recognizing that work is just a fraction of your overall life experience, we are dedicated to providing robust support. As a fully remote company, we prioritize flexibility and balance. Explore our comprehensive list of benefits at Zoneandco.com. Zone and Co is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. We strongly encourage candidates of all different backgrounds and identities to apply. This is an opportunity for us to bring in a different perspective and we’re eager to further diversify our company. Zone & Co is committed to building an equitable, inclusive, and supportive place for you to do some of the greatest work of your career. #LI-Remote

Title: Lead Clinical Applications Specialist Location: Remote Full time job requisition id: R4040228 Job Description: The Optison Product Clinical Specialist provides industry leading applications support for the development of Ultrasound Enhancing agents in Echocardiography exams. As the specialist you will act as clinical “voice of the customer”. Deliver in-service education presentations to customers in large and small group settings and provide product demonstrations to customers. Cross-functionally, you will work closely with sales, marketing, and other internal stakeholders. You will stay on-label in all discussions, education, and training, both internal and external customers. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Responsibilities: - Provide clinical support for the development of Ultrasound Enhancing Agents. - Apply knowledge of clinical Echocardiography to guide definition and development of new imaging and post-processing techniques. - Assist with trials, implementation, training, and Echocardiography Ultrasound Enhancing Agents. - Develop (clinical) competitive intelligence to support the field with counter arguments and selling advantages. - Represent and assist at local, regional, or National trade shows and meetings, as required - Demonstrate effective sales and presentation skills in diverse settings from one-on-one to formal large group situations, in-person and virtually Qualifications: - Preferred ARDMS, CCI certified or global equivalent - Experienced in Echocardiography including all clinical applications and performing procedures - At least 5 yrs. of experience in the medical industry - Ability to work independently, as well as within a team - Customer contact experience in various situations - Ability to travel 50% of the time (2-3 Overnights) - Demonstrate strong organizational, written, and verbal communication skills Preferred Knowledge/Skills: - Bachelors or 5 years equivalent experience - Ultrasound Enhancing Agent application experience - Echocardiography experience We will not sponsor individuals for employment visas, now or in the future, for this job opening. Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No

Title: Political & Lobby Compliance Specialist Location: Sacramento Full time Job Description: Greenberg Traurig (GT), a global law firm with locations across the world in 15 countries, has an exciting employment opportunity for you. We offer competitive compensation and an excellent benefits package, along with the opportunity to work within an innovative and collaborative environment. Join our Government Law & Policy Team as a Political and Lobby Compliance Specialist located in our Sacramento office. We are seeking a highly skilled professional who thrives in a fast-paced, deadline-driven environment. The ideal candidate possesses strong problem-solving and decision-making abilities, ensuring efficiency and accuracy in every task. With a dedicated work ethic and a can-do attitude, you will take initiative and approach challenges with confidence and resilience. Excellent communication skills are essential for collaborating effectively across teams and delivering exceptional client service. If you are someone who demonstrates initiatives, adaptability, and innovation, we invite you to join our team. This role will be based in our Sacramento office, on a hybrid basis. Regular in-office presence is required for day-to-day operations, as well as for team meetings, training opportunities, and relationship building. Position Summary The Political and Lobby Compliance Specialist position will provide organizational and practice specific support to attorneys in our highly specialized Government Law & Policy team in the Firm’s Sacramento Office. This position assists the team in a wide range of political and lobbying matters including preparing various regulatory reports for political candidates, committees, and non-profit organizations as well as administering lobbying reports for the Firm’s clients at the Federal Level and in all 50 states. Key Responsibilities - Administration of books for Federal, state, and local political candidates as well as those for political action committees and non-profit organizations. - Routine bookkeeping and administration of client financial accounts. - Preparation and filing of campaign finance reports and communicating timely financial information to clients. - Administration of lobby reports for clients at the Federal and State level. - Maintaining calendar of filing deadlines for lobbying reports. - Communicating with clients to gather information for public lobby reports. - Preparation and filing of lobby reports in a timely manner. - Work overtime as needed. - Any other duties and/or special projects as assigned. Qualifications Skills & Competencies - Ability to communicate professionally and interact effectively with all levels of personnel, including management staff and support staff - Excellent interpersonal and communication skills (oral and written), professional demeanor, and presentation - Demonstrates strong analytical and problem-solving skills and is a proactive self-starter who understands the details within a much larger context - Strong attention to detail and outstanding organizational skills - Excellent customer service skills and ability to work on multiple matters simultaneously in an organized manner and under minimal supervision - Ability to work under pressure to meet strict deadlines and respond quickly and positively to shifting demands Education & Prior Experience - Bachelor’s Degree in political science, law, business administration, or accounting preferred - A minimum of five years of experience, preferably with a political candidate, consultancy firm, political law firm, professional treasury firm, or in an AMLAW-100 law firm Technology - Proficiency in Microsoft Programs including Word, Outlook, PowerPoint, and Excel as well as QuickBooks - Exceptional computer skills with the ability to learn new software applications quickly The expected pay range for this position is: $37.28 - $39.32 per hour Actual pay will be adjusted based on experience, location, and other job-related factors permitted by law. Full time employees may be eligible for a discretionary bonus, health insurance with an optional HSA, short term disability, long term disability, dental insurance, vision care, life insurance, Healthcare and Dependent Care Flexible Spending Accounts, 401K, vacation, sick time, and an employee assistance program. Additional voluntary programs include: voluntary accident insurance, voluntary life, voluntary disability, voluntary critical illness and cancer insurance and pet insurance. Commuter and Transit programs may also be available in certain markets. GT is an EEO employer with an inclusive workplace committed to merit-based consideration and review without regard to an individual’s race, sex, or other protected characteristics and to the principles of non-discrimination on any protected basis.