Senior Director of Global Regulatory Strategy - Regulatory Affairs

At Olema Oncology, we are committed to pioneering advanced therapies for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is an innovative complete estrogen receptor antagonist (CERAN) currently undergoing development for metastatic breast cancer, showing significant promise as both a monotherapy and in combination therapy for ER+/HER2- metastatic breast cancer. Additionally, our next candidate, OP-3136, is a leading KAT6 inhibitor with potential to set new standards in treatment.Our scientific advancements are driven by an environment that encourages fearless support, motivation, and collaboration. At Olema, we believe that prioritizing our team leads to exceptional outcomes. If you are prepared to be part of something transformative, let’s collaborate to create meaningful impacts for our patients, your career, and the future of medicine.For more insights, view our latest corporate presentations here.About the Role: Senior Director, Global Regulatory Strategy Lead - Regulatory AffairsIn the position of Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs, reporting to the Senior Vice President of Regulatory Affairs, your key responsibilities will include:Leading the development of the New Drug Application (NDA).Creating and implementing innovative regulatory strategies that support Olema's product portfolio.Acting as the subject matter expert for Regulatory Affairs on cross-functional teams, providing guidance to global project teams, Study Execution Teams, and the Executive Committee.Offering strategic and tactical oversight for the development of regulatory submissions, including INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.This role is based in either our Boston, MA or San Francisco, CA office and will involve domestic and international travel of up to 20%.This role will primarily involve:Leading the NDA development and submission for our lead programFormulating innovative global regulatory strategies for the Olema product suite, addressing both clinical development and lifecycle management as required.Representing Regulatory Affairs on cross-functional teams as the SME, delivering regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.

Join AbbVie as the Director of Global Regulatory Strategy, where you will lead the development and implementation of regulatory strategies on a global scale, ensuring compliance and facilitating the approval process for innovative therapies. This role demands a strategic thinker with a deep understanding of regulatory landscapes and strong leadership capabilities.

As the Director of Global Regulatory Strategy at AbbVie, you will lead the development and implementation of regulatory strategies for our innovative product pipeline. This pivotal role will require you to collaborate with cross-functional teams, ensuring compliance with global regulations while driving the advancement of our therapeutic solutions.Your strategic vision will guide regulatory submissions and interactions with health authorities worldwide, facilitating our mission to provide transformative treatments to patients.

We are seeking an experienced Associate Director of Global Regulatory Strategy to drive our international regulatory initiatives. This pivotal role will involve developing and executing regulatory strategies for our innovative therapies aimed at treating serious diseases. You will collaborate closely with cross-functional teams to ensure compliance and facilitate the successful progression of our clinical programs.

At WHOOP, we are dedicated to enhancing human performance and extending health span. Our mission is to empower individuals to achieve peak performance through a profound understanding of their own bodies and daily routines.We are currently seeking a talented Regulatory Affairs Specialist II to join our innovative Digital Health team at WHOOP. This pivotal role involves executing regulatory strategies and ensuring the effective maintenance of our Quality Management System (QMS) for Software as a Medical Device (SaMD) in a fast-paced and adaptive environment. You will be instrumental in navigating the complexities of regulatory compliance, requiring creative problem-solving skills and the ability to thrive amidst evolving challenges.

Role overview The Director of Global Regulatory Strategy at AbbVie Inc. plays a central part in shaping and delivering regulatory strategies for therapies across international markets. Based in Boston, this leader manages a team dedicated to maintaining compliance with global regulations and contributes to the progress of new treatments. The position requires both strategic vision and hands-on leadership to guide regulatory activities worldwide. What you will do Lead and mentor a team responsible for developing and executing regulatory strategies for product registration in multiple countries. Interpret and address international regulatory requirements to facilitate product development and approval processes. Collaborate with internal stakeholders to ensure regulatory plans align with broader business objectives. Offer guidance on complex regulatory challenges to support the advancement of AbbVie’s therapies.

Join Sobi as the Associate Director of Global Medical Affairs, leading innovative medical strategies in the field of Haematology. In this pivotal role, you will drive the development and execution of medical programs that enhance patient outcomes and contribute to the advancement of our therapeutic areas.

Synerg seeks a Vice President of Regulatory Partnerships to join the team in Boston, Massachusetts. This executive role focuses on developing and managing relationships with regulatory agencies. The position plays a critical part in supporting Synerg’s mission by guiding key initiatives and ensuring compliance efforts match organizational goals. Role overview The Vice President will work closely with regulators, shaping strategies that strengthen Synerg’s standing with oversight bodies. This leader will also provide direction for compliance activities, making sure they fit the company’s broader objectives. What you will do Lead efforts to build and maintain partnerships with regulatory bodies Oversee compliance strategies and ensure alignment with company goals Collaborate with internal teams and external stakeholders to advance regulatory initiatives Location This position is based in Boston, Massachusetts, United States.

The Associate Director of Alumni Affairs and Development at Harvard University focuses on alumni engagement, shaping and delivering programs that build strong connections between the university and its alumni community. This role plays a key part in fostering relationships and supporting Harvard’s mission through meaningful engagement initiatives. Key Responsibilities Design and carry out strategies that connect alumni to Harvard and to each other. Oversee a variety of alumni programs, ensuring they align with the university’s goals and encourage active participation. Manage donor relations and maintain consistent communication with Harvard graduates. Collaborate with colleagues across departments to enhance the overall alumni experience. Requirements Experience in alumni relations or a closely related field. Strong interpersonal and communication abilities. Dedication to supporting Harvard’s mission. Proven ability to work well with both internal teams and external partners. Location This position is based in Boston.

At WHOOP, we are dedicated to enhancing human performance and extending healthspan through innovative technology. We are seeking an experienced Director of Hardware Product Compliance to spearhead our global compliance and certification initiatives. In this pivotal role, you will ensure that our cutting-edge products adhere to all relevant regulatory, safety, and quality standards across various international markets. This position requires a blend of strategic vision and hands-on execution, playing a crucial role in facilitating timely product launches, maintaining regulatory integrity, and ensuring global market accessibility. As WHOOP expands its international presence, you will have the opportunity to design, streamline, and elevate our product compliance function. You will establish the necessary systems, processes, and team dynamics to support our growing and increasingly intricate product portfolio. Collaborating closely with product development, engineering, operations, and executive leadership, you will integrate compliance seamlessly into the product lifecycle—from initial concept to market release—while balancing innovation, speed, and regulatory adherence in a fast-paced, growth-driven environment.

At Olema Oncology, our mission is to revolutionize the landscape of breast cancer treatment and beyond. We are at the forefront of drug development with our lead candidate, palazestrant (OP-1250), a complete estrogen receptor antagonist (CERAN) currently being developed for metastatic breast cancer. This innovative therapy has the potential to become a blockbuster, both as a standalone treatment and in combination with other therapies for ER+/HER2- metastatic breast cancer. Additionally, we are developing OP-3136, a powerful KAT6 inhibitor that showcases best-in-class potential.Our progress is fueled by a culture of fearless support, motivation, and collaboration. At Olema, we prioritize our people, ensuring that our efforts lead to groundbreaking advancements in patient care. If you are eager to be part of a transformative journey that impacts patients, propels your career, and expands the horizons of oncology, we welcome you to join our dynamic team.Explore our latest corporate presentations here.About the Role: Program Manager, CMCAs the Program Manager, CMC, you will report to the Director of CMC Program Management and be pivotal in leading integrated CMC program planning and execution throughout clinical development stages. Your role will be to convert CMC strategies into actionable, cohesive plans that facilitate timely clinical and regulatory advancements. This position demands extensive cross-functional collaboration with teams from Technical Operations (CMC technical leads), Quality, Regulatory, Supply Chain, Finance, and external partners. You will be recognized as an operational leader, responsible for driving accountability, fostering alignment, managing risks, and guiding teams through challenges effectively.This position may be located in either our San Francisco, CA or Boston, MA offices, with a requirement for 10% travel.Your primary responsibilities will include:Leading integrated CMC planning across Drug Substance (DS), Drug Product (DP), Analytical (AC), Quality (QA), Regulatory (RA), and Supply Chain (SC), collaborating with Director- and Senior Director-level leaders to define deliverables, timelines, and priorities that align with clinical and regulatory objectives.Developing and maintaining integrated project timelines using Smartsheet or similar tools to ensure project milestones are met efficiently.

At Veeva Systems, we are dedicated to revolutionizing the life sciences industry through innovative cloud-based solutions. Our mission is to accelerate the delivery of therapies to patients, and we've established ourselves as a leader in this space, achieving over $3 billion in revenue last fiscal year. As a rapidly expanding SaaS company, we are poised for significant growth in the years to come. Our core values drive us: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), ensuring a commitment to balancing the needs of our customers, employees, society, and investors. As a Work Anywhere organization, we value flexibility, allowing you to choose whether to work from home or in the office to maximize your productivity and comfort. Join us as we transform the life sciences landscape and make a meaningful impact on our customers, employees, and communities.About the Role In the capacity of Director of Regulatory Market Strategy, you will serve as the leading authority on Regulatory Information Management (RIM) at Veeva. This is a prestigious, non-managerial role, focusing on mastering the complexities of regulatory requirements and aligning them with cutting-edge software solutions. Your primary responsibility will be to enhance Veeva’s market share in regulatory products. What Makes This Role Stand OutStrategic Influence: Instead of managing a team, you will shape the strategies that enable biotech companies to navigate critical health authority submissions.Expertise Matters: Leveraging your dual expertise as an Operator and Consultant, you will provide insightful guidance that resonates with clients. Your experience will empower you to demonstrate how strategies can be applied effectively in global submissions.Commercial Significance: You will be more than a support role; you will be a key player in identifying market opportunities and collaborating with Product teams to ensure Veeva maintains its position as an industry leader. What This Role Is NOTNo People Management: You will be an elite individual contributor, with success evaluated based on market impact rather than team size.Not Regulatory Affairs or Science: This role is about designing systems to enhance product delivery to market, not developing regulatory strategies for sponsors.Transformative Technology Solutions: Your focus will be on delivering effective technology solutions that drive change.

About EyebotEyebot is a visionary technology firm dedicated to revolutionizing vision care accessibility for all. Based in the vibrant North End of Boston and supported by esteemed investors and the National Science Foundation, our innovative vision test kiosk is transforming the delivery of vision care.If you are driven by the passion to tackle significant challenges while helping to shape the future of vision care, we eagerly invite you to connect with us.About the RoleWe are seeking a dynamic Head of Regulatory Strategy & Clinical Development to chart our market approach. In this pivotal role, you will craft and implement the FDA regulatory strategy for our cutting-edge AI-powered ophthalmic diagnostic platform, managing 510(k) submissions, Pre-Submissions, and CE marking compliance under the EU MDR. This leadership position offers direct visibility to executives and significant influence over product outcomes.Your Responsibilities:U.S. FDA StrategyEstablish and execute comprehensive FDA regulatory strategies, including predicate selection, intended use definition, and risk assessment.Lead the drafting and submission of Pre-Submission and 510(k) applications from inception to clearance.Act as the primary liaison for all FDA interactions, including meetings, Q-Submissions, and formal communications.Ensure risk management, labeling, and software documentation align with FDA guidelines.EU CE MarkingDirect the EU MDR regulatory strategy and manage the CE marking process comprehensively.Create and uphold the Technical File; facilitate interactions and audits with Notified Bodies.Monitor post-market surveillance and vigilance, ensuring consistency between U.S. and EU regulatory perspectives.Clinical Strategy & ExecutionIdentify when clinical evidence is necessary and specify the required evidence scope.Design and implement clinical study protocols and statistical analysis plans.Oversee IRB submissions, site coordination, study execution, data integrity, and final reporting.Program & Cross-Functional LeadershipManage regulatory program timelines across hardware, software, clinical, and labeling workflows.

WHOOP is seeking a talented Associate Creative Director, Art who possesses a profound ability to visually convey a brand’s identity and vision. As a vital member of our Marketing team and a senior authority within the Creative team, you will not only maintain our brand standards but also drive their evolution. You are a strategic visionary who thrives on both leadership and hands-on creative work. Your passion for mentoring designers is matched only by your commitment to delivering impactful creative solutions that yield measurable results.

At Real Chemistry, our commitment to making the world a healthier place is more than a goal – it’s our daily reality. We harness a unique blend of scientific expertise, human-centered creativity, and AI-driven insights to drive innovation in healthcare. As a leading global agency, we offer a comprehensive range of services in healthcare communications and marketing to esteemed clients in the pharmaceutical and biotech sectors.Our vibrant culture at #LifeatRealChem is built around our people; we thrive in collaboration and strive for excellence, both for our clients and our colleagues. Whether you are an experienced professional or just beginning your career journey, if you share our dedication to healthcare and meaningful connections, we encourage you to explore our opportunities.Find your purpose. Embrace innovation. Experience #LifeatRealChem.Job Summary:Real Chemistry is excited to invite an Associate Director of Strategy to our expanding team!21GRAMS, a division of Real Chemistry, approaches advertising with a focus on humanizing healthcare. We believe in fostering positive relationships, both internally and externally, and adhere to the principle of 'Be good to each other, but hard on the work.' If you’re looking to make a meaningful impact, this is the place for you.This hybrid role may be based in any of our US offices—including New York City, Boston, Chicago, Carmel, Lambertville, or San Francisco—or can be performed remotely, depending on team and business needs.Responsibilities:Lead the creation of brand positioning, messaging, and creative briefs that effectively relay our brand narrative.Collaborate closely with cross-functional teams, including Account Management, Creative, and Project Management, to design integrated omnichannel campaigns that yield measurable outcomes.Stay updated on industry trends, emerging technologies, and best practices in omnichannel strategy.

Role overview Oscar seeks an Associate Director of Tax in Boston, Massachusetts. This leader oversees tax compliance and helps shape the company’s tax strategy. The position works closely with teams across the business to align tax plans with both organizational goals and regulatory standards. Key responsibilities Lead tax compliance efforts and keep processes current. Work with internal partners to ensure tax strategies support business needs and legal obligations. Spot and assess opportunities for tax savings. Handle tax audits and related communications. Supervise timely and accurate tax reporting. Impact This position shapes Oscar’s financial planning and supports efficient tax operations. The Associate Director of Tax provides expertise in both daily compliance and long-term tax strategy.

As the Associate Director of External Partnerships at precede, you will play a pivotal role in cultivating and managing strategic relationships that drive our mission forward. This position involves collaborating with diverse stakeholders to identify partnership opportunities, negotiating agreements, and ensuring that our partnerships align with our organizational goals.

As the Associate Director of Analytical Development at Olema, you will play a pivotal role in advancing our drug development programs. You will lead analytical strategy, oversee method development and validation, and ensure compliance with regulatory standards. Your contributions will directly impact the success of our clinical trials and the delivery of innovative therapies to patients.

Join Veeva Systems, a pioneering mission-driven organization that is revolutionizing the life sciences sector by enabling companies to deliver therapies to patients more swiftly. As one of the fastest-growing SaaS companies in history, we proudly achieved over $2 billion in revenue last year, with an exciting trajectory of further growth.At the core of Veeva are our guiding principles: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), committed to balancing the needs of our customers, employees, society, and investors.As a Work Anywhere company, we embrace the flexibility of working from home or in the office, allowing you to thrive in your preferred environment.Join us in transforming the life sciences industry and making a meaningful impact on our customers, employees, and communities.The RoleVeeva Link is dedicated to enhancing engagement with Key Opinion Leaders in Healthcare. Our applications vary in maturity, with some being industry standards while others are in their early stages. There’s a wealth of knowledge to absorb and ample opportunities for professional growth. Our Strategy team is pivotal to the market success of our products, overseeing everything from product development to client satisfaction. We are seeking a candidate who embodies our relentless drive to transform the industry, possesses expertise in biopharma and technology, and is genuinely passionate about building relationships.

Walker Sands strongly encourages individuals from diverse backgrounds, including people of color, LGBTQIA+ individuals, veterans, parents, and those with disabilities, to apply. We are an equal opportunity employer committed to fostering a diverse and inclusive workplace.In your application, please feel free to indicate your preferred pronouns (e.g., she/her/hers, he/him/his, they/them/theirs).If you require reasonable accommodations during the application or interview process, please do not hesitate to reach out.About the RoleWalker Sands is on the lookout for an Associate Director of Content Strategy to lead the evolution of our content delivery, driving impactful business outcomes for B2B brands.This senior, client-facing position requires a blend of strategic insight and practical expertise in demand generation content. You will closely collaborate with our paid media, strategy, analytics, and additional teams to design and implement content that supports integrated campaigns from initial engagement through to conversion.In this role, you will be pivotal in shaping demand generation content initiatives, guiding both clients and internal teams to ensure our outputs are not only well-crafted but also effective.Key ResponsibilitiesLead Demand Generation Content StrategyDevelop comprehensive content strategies that bolster integrated demand generation campaigns and meet conversion objectives.Collaborate with paid media, strategy, analytics, and other teams to synchronize messaging with target audiences, channels, and campaign methodologies.Oversee the creation of essential campaign materials, including emails, landing pages, and lead generation content.Utilize performance metrics and A/B testing to continuously enhance and refine content.Contribute to new business initiatives through insightful strategic planning and client discussions.Create and Elevate B2B ContentManage and contribute to a diverse range of content, including campaign materials, blogs, bylines, ebooks, white papers, and research reports.Step in as the lead writer or editor for complex or high-priority projects.Assist clients in translating intricate concepts into clear, credible, and engaging content.Ensure content aligns with buyer needs, channel expectations, and performance metrics.Act as a trusted advisor to clients, identifying opportunities for content enhancement.