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• Define and execute global CMC regulatory strategies for investigational and marketing applications.
• Lead preparation, review, and approval of CMC sections for regulatory submissions.
• Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.

BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.

• Global Regulatory Lead for a cutting edge RPT programs
• Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products
• Lead the preparation and submission of regulatory filings

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, develops transformative radiopharmaceutical therapies. They blend the spirit of an emergent biotech with the expertise and resources of a leading innovator in oncology, fostering a multidisciplinary team where ideas are valued.

• Define and manage SOPs in collaboration with stakeholders and technology partners.
• Use data and market landscape tools to generate hypotheses and validate assumptions.
• Understand the problem space to inform early strategic options.

Aledade empowers independent primary care practices to deliver better care and thrive in value-based care. They are the largest network of independent primary care in the country with a collaborative, inclusive, and remote-first culture.

• Lead the Italy Market Access & Public Affairs strategy for current and future vaccines.
• Provide strategic leadership for regional access across Italy, setting engagement priorities and access models.
• Define and execute Italy public affairs activities in alignment with national priorities and business objectives.

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). Since its founding in 2010, Moderna has aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.

• Support Headway health plan partnerships and strategy.
• Drive creative, innovative, exploratory data analyses to prove patient outcomes.
• Work collaboratively with cross functional teams including product, design, growth, marketing, payer relations, data & analytics, and operations.

Headway is building a new mental healthcare system that everyone can access. They have grown into a national network of over 60,000 mental healthcare providers across all 50 states. They are a Series D company with over $325m in funding.

• Acting as first point of contact for all inbound compliance queries, routing matters as necessary to appropriate team members and tracking completion
• Supporting and coordinating recurring compliance tasks that help mitigate regulatory risk to the company
• Assisting with preparation and submission of routing regulatory filings such as state registrations and annual reports

Virta Health is dedicated to reversing metabolic disease in one billion people through personalized nutrition and virtual care. They have raised over $350 million and partner with health plans, employers, and government organizations.

• Own and execute program and portfolio management strategy across Akero’s development organization.
• Serve as primary cross functional integrator, ensuring alignment between strategy, execution, governance and decision making across programs.
• Partner with Development Therapeutic Area VPs and senior leaders to advance strategic priorities and ensure clear accountability, ownership, and decision rights.

Akero Therapeutics, a Novo Nordisk company, is focused on discovering and developing treatments for patients with metabolic diseases. They are a team of problem solvers dedicated to pursuing scientific approaches for patients.

• Lead development and execution of global regulatory strategy.
• Act as a subject matter expert in regulatory affairs for product introduction.
• Participate in quality system and design dossier audits.

Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.

• Provide regulatory compliance risk assessment and consultation.
• Assist financial services clients in strengthening their compliance management systems.
• Conduct regulatory compliance testing for federal consumer compliance regulations.

Wipfli provides accounting and consulting services. Their people are the core of their business, and they focus on relationships while encouraging individuals to follow their own path.

• Own marketing strategy and deliverables for high-complexity projects.
• Develop target product profiles, value propositions, and business cases.
• Integrate clinical insights into marketing strategy to reflect patient outcomes.

Maine General is partnered with Jobgether to find a Senior Upstream Product Marketing Manager to drive innovative marketing strategies for their dental product portfolio. The company offers remote work flexibility and opportunities for professional development and growth.

• Managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
• Ensuring that new products and documentation are compliant with applicable quality and regulatory requirements.
• Serving as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, and post-clearance activities.

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity.

• Serve as key person between Medical Affairs and cross-functional partners.
• Proactively identify inefficiencies and duplication of effort across Medical Affairs.
• Maintain and continuously optimize Medical Affairs SOPs and policies.

EyePoint is a patient-centric and award-winning ophthalmology company that focuses on science and innovation to offer a lifetime of clearer vision. They specialize in sustained-release treatments for serious retinal diseases and empower curiosity and innovation in a science-based entrepreneurial culture.

• Support strategic partner relationships and drive thought leadership.
• Develop multi‑year account plans and refine programs based on needs.
• Create clear, data‑driven recommendations by interpreting performance.

Phreesia's SaaS platform digitizes appointment check-in and offers tools to engage patients, improve efficiency, optimize staffing, and enhance clinical care. They are a five-time winner of Modern Healthcare Magazine’s Best Places to Work in Healthcare award and they’ve been recognized on the Bloomberg Gender Equality Index.

• Lead commercial strategy and sales of NIQ's solutions as part of client contract renewals or RFPs.
• Develop commercial elements of joint business plan and NIQ account plans & sales strategy.
• Build meaningful client relationships with client stakeholders and teams.

NielsenIQ is a consumer intelligence company, delivering understanding of consumer buying behavior. They combined with GfK in 2023 and operate in 100+ markets, covering more than 90% of the world’s population, committed to diversity, equity, and inclusion.

• Lead the development and implementation of regulatory and quality assurance strategies.
• Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
• Act as an internal SME (Subject Matter Expert) on regulatory requirements.

Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.

• Lead the development, manufacturing, assembly, and commercialization of high‑concentration biologic delivery systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks.

Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. It appears to be a growing company with a focus on innovation.

• Serve as the primary legal advisor to Liberty’s North America Casualty line of business and Programs portfolio.
• Advise on domestic insurance regulatory issues impacting casualty products and programs across admitted and E&S markets.
• Structure, draft, and negotiate program-related agreements and distribution arrangements.

Liberty Mutual is a global insurance company. They offer a wide range of insurance products and services, striving to create a workplace where everyone feels valued and supported, with inclusion embedded in every aspect of their culture.

• Provide senior strategic Regulatory CMC leadership across Antares’ portfolio.
• Advise on CMC readiness for INDs and global CTAs, ensuring alignment with clinical development plans and corporate objectives.
• Guide the integration of CMC regulatory considerations into early development, manufacturing, and supply decisions.

Antares Therapeutics is focused on bringing transformative oncology therapies to patients. They operate with cross-functional teams including Global Regulatory Affairs, Technical Operations, Quality, and Supply Chain to meet corporate objectives.

• Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
• Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
• Remain current on regulations and best practices within the industry

Nuvalent is dedicated to creating selective medicines to address the unmet needs of patients with cancer, leveraging their expertise in chemistry. As an early-stage entity, Nuvalent brings together seasoned scientists and industry experts with a strong history in oncology drug development, drug discovery, and company building.

• Serve as a subject-matter expert on global clinical and regulatory writing projects
• Lead the writing, review, and coordination of complex documents such as CTD Modules, Clinical Study Protocols, and Clinical Study Reports
• Drive development of key clinical documents that align with overall program and submission strategy

Jobgether is a company that uses AI-powered matching to ensure applications are reviewed quickly, objectively, and fairly. Their system identifies the top-fitting candidates and shares this shortlist directly with the hiring company.