Senior Director, Regulatory Affairs
1 month ago
HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.
We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. Objectives / Overview:The Sr Director, Regulatory Affairs is accountable for developing regulatory strategies for norovirus vaccine candidates with an emphasis on European requirements for early and late stage assets. This person will be a key regulatory leader who partners with internal and external stakeholders to achieve successful regulatory filings and approvals in Europe, US and international. The successful candidate will have significant regulatory experience in vaccine development with a focus on Europe and the US. Responsibilities:
- Implement the regulatory strategies for early and late stage assets and actively contribute to the associated clinical development plans.
- Provide critical regulatory input to cross functional internal teams, external CROs and consultants in the planning, organizing, and submission of regulatory dossiers to EMA, European NRAs and other global regulatory agencies.
- Translate current regulatory requirements into practical submission strategies in Europe and worldwide.
- Liaise with CROs to prepare clinical content of submissions in Latin America and Asia.
- Track and evaluate changes to regulatory requirements and guidelines as they impact development of company assets.
- Minimum of a bachelor’s degree in a related Science Field; advanced degree in Science desirable
- A minimum of 7 years of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility. Experience with vaccines preferred.
- A working knowledge of US, EU and international regulatory and GxP standards relevant to the development and approval of new vaccines.
- Direct experience leading and preparing for regulatory agency meetings
- Extensive knowledge of clinical trial designs and global reporting requirements
- Experience developing the clinical and labeling content and format for original and supplemental license applications.
- The ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (regulatory authorities, vendors, investigators, and other stakeholders).
- Ability to work in a fast paced/flat/dynamic small company environment
- Excellent influencing and negotiating experience and capabilities in a matrix environment
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.
- Proficient with Microsoft Office and Veeva Vault applications, Adobe and document management templates.
HilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burdens.
We are founded on the legacies of leading vaccine developers that inspire us to have a positive impact on human health and build a company that equalizes opportunity for people around the world by removing barriers of health inequity. Our aim is to have a global impact on human health; we believe the best way to achieve this impact is by developing novel vaccines for severe and life-threatening diseases. Objectives / Overview:The Sr Director, Regulatory Affairs is accountable for developing regulatory strategies for norovirus vaccine candidates with an emphasis on European requirements for early and late stage assets. This person will be a key regulatory leader who partners with internal and external stakeholders to achieve successful regulatory filings and approvals in Europe, US and international. The successful candidate will have significant regulatory experience in vaccine development with a focus on Europe and the US. Responsibilities:
- Implement the regulatory strategies for early and late stage assets and actively contribute to the associated clinical development plans.
- Provide critical regulatory input to cross functional internal teams, external CROs and consultants in the planning, organizing, and submission of regulatory dossiers to EMA, European NRAs and other global regulatory agencies.
- Translate current regulatory requirements into practical submission strategies in Europe and worldwide.
- Liaise with CROs to prepare clinical content of submissions in Latin America and Asia.
- Track and evaluate changes to regulatory requirements and guidelines as they impact development of company assets.
- Minimum of a bachelor’s degree in a related Science Field; advanced degree in Science desirable
- A minimum of 7 years of regulatory experience in a pharmaceutical/biologics company with demonstrated increasing expertise and responsibility. Experience with vaccines preferred.
- A working knowledge of US, EU and international regulatory and GxP standards relevant to the development and approval of new vaccines.
- Direct experience leading and preparing for regulatory agency meetings
- Extensive knowledge of clinical trial designs and global reporting requirements
- Experience developing the clinical and labeling content and format for original and supplemental license applications.
- The ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (regulatory authorities, vendors, investigators, and other stakeholders).
- Ability to work in a fast paced/flat/dynamic small company environment
- Excellent influencing and negotiating experience and capabilities in a matrix environment
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.
- Proficient with Microsoft Office and Veeva Vault applications, Adobe and document management templates.
- Location in Bostonpreferred; remote or hybrid options will be considered.
- Willingness to travel (20-25%) to various meetings or client sites, including overnight trips and international travel.
HilleVax is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We welcome all to apply.
Who referred you to this position? Enter their first and last name here.
What's your citizenship / employment eligibility?*
Are you 18 years of age or older?
Desired salary *
References: Please enter names and contact information:
#J-18808-Ljbffr-
Senior Director, Regulatory Affairs
3 weeks ago
Boston, Massachusetts, United States Proclinical Full timeSenior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...
-
Senior Director, Federal Affairs
1 week ago
Boston, United States BlueCross & BlueShield of Massachusetts Full timeThe Senior Director, Federal Government Affairs will manage BCBSMA activities to achieve effective and time-sensitive advancement of BCBSMA legislative and regulatory agenda in a coordinated and integrated fashion. Key Accountabilities: Manage BCBSMA Director, Senior, Regulatory Affairs, Vice President, Government, Insurance, Policy
-
Director/Assoc Director Regulatory Affairs
4 weeks ago
Boston, United States Apex Systems Full timeJob#: 2025096 Job Description: Associate Director/Director, Regulatory Affairs 2025096 Location: Boston, MA(Remote) Therapeutic Areas : Neuro Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation,...
-
Regulatory Affairs Director
2 weeks ago
Boston, Massachusetts, United States Foundation Medicine Full timeAbout the JobThe Regulatory Affairs (RA) Director is responsible for the development and implementation of a comprehensive global regulatory strategy that supports the evolution and enhancement of FMI's unparalleled global portfolio of assay products, including companion diagnostics. This role is responsible for international regulatory strategy, including...
-
Senior Manager Regulatory Affairs, Strategy
3 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the...
-
Senior Director, Regulatory Strategy
4 weeks ago
South Boston, United States Inozyme Pharma Full timeSenior Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton.Position Overview: As the Senior Director of Regulatory Strategy, you...
-
Senior Manager Regulatory Affairs, Strategy
4 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological...
-
Senior Manager Regulatory Affairs, Strategy
4 weeks ago
Boston, United States Inozyme Pharma Full timeSenior Manager/Associate Director, Regulatory StrategyCompany Overview:Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological...
-
Senior Director, Regulatory Affairs
4 weeks ago
Boston, United States HilleVax, Inc. Full timeHilleVax is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. Our initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection. It is estimated that norovirus causes nearly 700 million cases...
-
Boston, Massachusetts, United States Gilead Sciences, Inc. Full timeFor Current Gilead Employees and Contractors:Please log onto your Internal Career Site $) to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access...
-
Boston, United States AstraZeneca Full timeAre 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...
-
Director, Regulatory Affairs Vaccines Cmc
1 month ago
Boston, United States ARIAD Full time**Pay Range**: $169,400.00 - $266,200.00 **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169,400.00 - $266,200.00**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four...
-
Director, Regulatory Affairs Vaccines Cmc
1 month ago
Boston, United States Takeda Pharmaceutical Full time**About the role**: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join...
-
Regulatory Affairs Manager
1 day ago
Boston, United States Pharvaris Full timePharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the...
-
Regulatory Affairs Manager
2 days ago
Boston, United States Pharvaris Full timePharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases, with offices in Switzerland (Zug), the Netherlands (Leiden) and the USA (greater Boston area). We aim at bringing new, more convenient options to HAE patients who suffer sudden and prolonged attacks of swelling in multiple areas of the...
-
Director, Regulatory Affairs
7 days ago
Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Principal Regulatory Affairs Specialist
21 hours ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob Description Job Description Principal Regulatory Affairs Specialist Job DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class...
-
Principal Regulatory Affairs Specialist
6 days ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob DescriptionJob DescriptionPrincipal Regulatory Affairs SpecialistJob DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class III...
-
Director, Regulatory Affairs
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
-
Boston, United States Inozyme Pharma Full timeCompany Overview: Inozyme Pharma,Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical companydeveloping novel therapeutics for the treatment of diseases of abnormalmineralization impacting the vasculature, soft tissue, and skeleton. Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the...
