Current jobs related to Director Regulatory Affairs, Late Cardiovascular, Renal and Metabolism - Waltham, Massachusetts - AstraZeneca
-
Regulatory Affairs Director
5 days ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Affairs CMC is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...
-
Regulatory Affairs Director
3 weeks ago
Waltham, Massachusetts, United States Dyne Tx Full timeAbout Dyne TxDyne Tx is a clinical-stage biotechnology company dedicated to developing innovative therapeutics for people living with genetically driven diseases.Job SummaryWe are seeking a highly experienced Regulatory Affairs Director to lead our CMC regulatory strategies for our programs in early and late-stage development. This role will support our...
-
Regulatory Affairs Director
10 hours ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne's clinical registration, commercial development, and...
-
Regulatory Affairs Director
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...
-
Regulatory Affairs Director
15 hours ago
Waltham, Massachusetts, United States Weber & Company Full timeExecutive Director Regulatory AffairsJob Summary:Weber & Company is seeking an experienced Executive Director Regulatory Affairs to lead our client's regulatory affairs team in Greater Boston. As a key member of the leadership team, you will be responsible for developing and implementing a regulatory strategy that accelerates product approvals and maintains...
-
Regulatory Affairs Director
6 days ago
Waltham, Massachusetts, United States Trebla Talent Full timeJob Title: Executive Director, Regulatory AffairsCompany: Trebla TalentLocation: Massachusetts - HybridJob Type: Full-timeAbout the Company:Trebla Talent is a leading recruitment agency specializing in placing top talent in the biotech and pharmaceutical industries.Job Description:We are seeking an experienced Executive Director to lead our Regulatory...
-
Regulatory Affairs Director
1 week ago
Waltham, Massachusetts, United States Trebla Talent Full timeRole:We are seeking a seasoned Regulatory Affairs expert to lead our team and drive strategic decisions across our portfolio.Company Overview:Trebla Talent is proud to partner with a pre-IPO, clinical-stage biotech company that is revolutionizing cancer and autoimmune treatments through innovative immunotherapies.Key Responsibilities:As the Executive...
-
Regulatory Affairs Director
1 week ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeAbout Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop innovative small molecule medicines for challenging targets. Our initial focus areas include immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and...
-
Regulatory Affairs Director
3 weeks ago
Waltham, Massachusetts, United States Muraloncology Full timeAbout the RoleMuraloncology is seeking a highly skilled and experienced Regulatory Affairs Director to lead our Regulatory Strategy team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support the approval and commercialization of our oncology products.Key...
-
Regulatory Affairs Director
1 week ago
Waltham, Massachusetts, United States Meet Full timeRegulatory Affairs Leadership OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.Key Responsibilities:Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departmentsDrive planning and implementation of meetings...
-
CMC Regulatory Affairs Expert
3 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of...
-
Regulatory Affairs Director
1 week ago
Waltham, Massachusetts, United States Meet Full timeRegulatory Affairs Leadership OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic direction in this critical role.Key Responsibilities:Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departmentsDrive planning and implementation of meetings...
-
Executive Director, Regulatory Affairs Lead
3 weeks ago
Waltham, Massachusetts, United States Trebla Talent Full timeJob Summary:We are seeking a highly experienced Executive Director, Regulatory Affairs to join our team at Trebla Talent. As a pivotal leader, you will drive strategic regulatory decisions across our entire portfolio, leading a growing regulatory team and reporting directly to the c-suite.Key Responsibilities:Develop and implement regulatory strategies to...
-
Waltham, Massachusetts, United States Weber & Company Full timeJob SummaryWeber & Company is seeking an experienced Executive Director of Regulatory Affairs and Compliance to lead our client's regulatory strategy and operations. This is a unique opportunity to join a dynamic team and contribute to the growth and success of a leading medical device company.Key ResponsibilitiesDevelop and implement a comprehensive...
-
Senior Director, Head of Regulatory Affairs
2 weeks ago
Waltham, Massachusetts, United States Ventus Therapeutics Full timeAbout Ventus Therapeutics:We are a biopharmaceutical company leveraging cutting-edge structural biology and computational chemistry tools to develop novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation, and neurology.Our proprietary drug discovery platform, ReSOLVE, enables us to discover and develop...
-
Global Regulatory Affairs Director
3 weeks ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeJob Summary:We are seeking a highly experienced Global Regulatory Affairs Director to lead the development and execution of regulatory strategies for our vaccines portfolio. As a key member of our Global Regulatory Affairs team, you will be responsible for ensuring compliance with regional regulatory requirements and delivering the best possible labeling for...
-
Waltham, Massachusetts, United States Syndax Pharmaceuticals, Inc. Full timeAbout Syndax Pharmaceuticals, Inc.Syndax Pharmaceuticals, Inc. is a leading biotechnology company dedicated to advancing innovative treatments for cancer patients. Our mission is to improve the lives of cancer patients by developing first-in-class solutions that provide meaningful and differentiated clinical results.Job SummaryWe are seeking an experienced...
-
Lead Manager, Regulatory Affairs and Strategy
4 weeks ago
Waltham, Massachusetts, United States AbbVie Full timeCompany Overview:AbbVie is dedicated to discovering and delivering innovative therapies that address significant health challenges today and in the future.Our goal is to positively impact lives across several key therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as through our Allergan Aesthetics portfolio.For further...
-
Waltham, Massachusetts, United States AbbVie Full timeCompany Overview:At AbbVie, our mission is to innovate and provide groundbreaking medicines and solutions that tackle significant health challenges today while preparing for the medical hurdles of tomorrow.We aim to make a substantial difference in the lives of individuals across various critical therapeutic domains, including immunology, oncology,...
-
Waltham, Massachusetts, United States Alkermes, Inc. Full timePosition Overview: In this pivotal role, reporting to the Senior Director of Regulatory Affairs, the Senior Manager of Regulatory Affairs and Compliance will oversee the provision of expert regulatory guidance pertaining to the dissemination of information regarding designated Alkermes products and relevant therapeutic areas. This position collaborates...
Director Regulatory Affairs, Late Cardiovascular, Renal and Metabolism
3 months ago
Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metabolism (CVRM) regulatory affairs to get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolioAstraZeneca's pipeline of innovative medicines is consistently growing within Cardiovascular, Renal and Metabolism (CVRM).
Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it – working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading CVRM Regulatory function, we're focused and committed to the development of our products as well as to our people – providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.We are more than people in over 100 countries. Our aim is simple to positively impact lives together.
Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the CVRM therapeutic area to a whole new level by seeking new treatments. We continue to expand our regulatory teams at AstraZeneca's dynamic R&D sites in Gaithersburg (US), Wilmington, DE (US),) and Gothenburg (Sweden).
If you are looking for a new challenge, we are offering opportunities in different disease areas and at different levels, depending on your expertise and previous experience.What You'll doAs a Regulatory Affairs professional within AstraZeneca, you will play a key role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs. In this way, our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world.Strategic thinking is key within our function.
The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.Essential for the roleIn combination with your regulatory expertise, successful candidates will demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills. It is important that you embrace the concepts of novel regulatory tools and technology as well as a culture of sharing experiences with others so that the medicines that we develop will benefit from latest approaches in regulatory science. You are comfortable speaking the regulatory voice at all levels of the organization.Academic degree in a science related field or equivalentExtensive knowledge of regulatory affairs within one or more therapeutic areas in early and late developmentProven track record of regulatory drug development including product approval/launch.Experience in leading Major Health Authority interactionsAbility to think strategically and critically and evaluate risks to regulatory activities.Ability to work strategically within a complex, business critical and high-profile development program.At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big.
Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together.
Interested? Come and join our journey.We are eager to know more about you. If you are interested to know more about us, apply nowAs AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026.
Find out more information here: Kendall Square Press ReleaseDate Posted21-Aug-2023Closing Date10-Sep-2023AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
