Senior Director, Head of Regulatory Affairs
1 week ago
About us:
Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.
Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated small molecule medicines. Our lead programs target key innate immune modulators, including NLRP3 and cGAS. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.
Position Overview:
The Senior Director of Regulatory Affairs and Quality is a hands-on leadership role. The position will have the responsibility to lead, manage and drive regulatory and quality (GxP) activities, policy and strategy, to interface with global regulatory agencies and corporate partners, and to provide executive management with regulatory metrics and information.
Key Duties and Responsibilities:
- Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
- Serve as Regulatory Affairs contact for external parties (for example, CROs, advisors) involved in the conduct of global clinical trials
- Develop and implement global regulatory strategy for submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, US FDA, EMA, PMDA, ICH, ISO)
- Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to Health Authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products
- Liaison with Health Authorities as needed
- Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
- Communicate project updates and risks to senior management and stakeholders across the organization
- Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
- Coordinate and prepare responses to requests for information from Health Authorities
- Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
- Maintain and develop standard operating procedures (SOPs) to ensure compliance with global GxP expectations.
- Oversee vendor qualification and oversight program
- Assess and manage internal regulatory and quality resources, including external consultants to ensure corporate objectives are met and risks are appropriately considered.
Requirements:
- Advanced Degree (PharmD, PhD, MPH, or equivalent) in a scientific field preferred
- 10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization
- Experience in development of SOPs and managing quality issues
- Experience in hosting and leading FDA and other regulatory authority audits, would be an advantage.
- Leadership and management experience in building high-performing teams through coaching and development
- Experience from IND through to marketing application, across all disciplines (nonclinical, clinical, CMC), as well as attending/running regulatory interactions
-
Senior Director, Head of Regulatory Affairs
2 months ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Senior Director, Head of Regulatory Affairs
2 months ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Senior Director, Head of Regulatory Affairs
4 days 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...
-
Head of Regulatory Affairs
7 days ago
Waltham, United States Muraloncology Full timeDescription:We are looking for a dynamic Head of Regulatory Affairs whose responsibilities include regulatory oversight and strategic development of our products throughout the product lifecycle. This individual will lead Regulatory Strategy, Regulatory Operations, and Regulatory CMC. Success in this role requires strong leadership skills, exceptional...
-
Senior Director, Head of Regulatory Affairs
4 weeks ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Senior Director, Head of Regulatory Affairs
2 weeks ago
waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Senior Director, Head of Regulatory Affairs
4 weeks ago
Waltham, United States Ventus Therapeutics Full timeAbout us:Ventus Therapeutics is a biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets, with an initial focus on immunology, inflammation and neurology.Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop...
-
Regulatory Affairs Director
5 days 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...
-
Senior Director, Regulatory Affairs
2 months ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Senior Director, Regulatory Affairs
2 months ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Regulatory Affairs Director
6 days 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...
-
Executive Director, Regulatory Affairs
6 days ago
waltham, United States Trebla Talent Full timeRole:Executive Director or Vice President, Regulatory AffairsMassachusetst - HybridCompany Description:This pre-IPO, clinical-stage biotech, a spinoff from MIT and Harvard, is a key player in advancing cancer and autoimmune treatments through cutting-edge immunotherapies. Its technology is the first to develop novel immune cell engager therapies like theirs!...
-
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...
-
Waltham, Massachusetts, United States Alkermes, Inc. Full timePosition Overview: Under the guidance of the Senior Director of Regulatory Affairs for Advertising, Promotion & Labeling, the Senior Manager, Regulatory Affairs in Advertising will play a pivotal role in delivering comprehensive regulatory guidance concerning the dissemination of information related to designated Alkermes products and associated medical...
-
Executive Director, Regulatory Affairs
7 days ago
Waltham, United States Trebla Talent Full timeRole:Executive Director or Vice President, Regulatory AffairsMassachusetst - HybridCompany Description:This pre-IPO, clinical-stage biotech, a spinoff from MIT and Harvard, is a key player in advancing cancer and autoimmune treatments through cutting-edge immunotherapies. Its technology is the first to develop novel immune cell engager therapies like theirs!...
-
Executive Director, Regulatory Affairs
6 days ago
Waltham, United States Trebla Talent Full timeRole:Executive Director or Vice President, Regulatory AffairsMassachusetst - HybridCompany Description:This pre-IPO, clinical-stage biotech, a spinoff from MIT and Harvard, is a key player in advancing cancer and autoimmune treatments through cutting-edge immunotherapies. Its technology is the first to develop novel immune cell engager therapies like theirs!...
-
Executive Director Regulatory Affairs
3 days ago
Waltham, United States Weber & Company Full timeTitle: Executive Director Regulatory AffairsLocation: Waltham, MAPosition Overview:Our Medical Device client, located in Greater Boston, has retained Weber & Company to help fulfill its Executive Director of Regulatory Affairs leadership position, which will open new markets and sustain its rapid growth.With sales approaching $1B, the client is reasserting...
-
Executive Director Regulatory Affairs
3 days ago
Waltham, United States Weber & Company Full timeTitle: Executive Director Regulatory AffairsLocation: Waltham, MAPosition Overview:Our Medical Device client, located in Greater Boston, has retained Weber & Company to help fulfill its Executive Director of Regulatory Affairs leadership position, which will open new markets and sustain its rapid growth.With sales approaching $1B, the client is reasserting...
-
Senior Regulatory Affairs Specialist
2 months ago
Waltham, United States EPM Scientific Full timeTitle: Senior Regulatory Affairs SpecialistThe Senior Regulatory Affairs Specialist will be responsible for:Lead preparation for global and US submissions such as 510k and IVD/IVDR related productsHandle pre and post market submissionsManage all aspects of IVDD/IVDR requirementsLead Health Canada and international device licensingSupport new product...
-
Associate Director, Regulatory Affairs CMC
2 months ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...