Director / Sr. Director Regulatory Affairs
vTv TherapeuticsUS6 days ago
Job type
- Full-time
- Quick Apply
Job descriptionRegulatory Affairs Reports To : VP, Regulatory Affairs Status : FTE About vTv vTv Therapeutics is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications, including type 2 diabetes and other chronic conditions. Description The Director / Sr Director of Regulatory Affairs, reporting to the VP / Head of Regulatory Affairs, will support the development our lead asset as well as our pipeline across therapeutic indications. We are seeking an innovative and agile candidate who will be responsible for regulatory strategy across all phases of development including active engagement with US and ex-US regulatory health authorities and cross functional collaboration to achieve the organizational goals. The ideal candidate brings substantial Regulatory Affairs experience and leadership, to navigate the vTv program(s) through the regulatory lifecycle. . Key Responsibilities Develop lead and execute against regulatory strategies through all phases of development of vTv programs from proof of concept through commercialization. Prepare for, lead and document health authority meetings and continue to liaise with health authorities throughout development. Provide regulatory guidance for internal and external project governance boards for vTv programs. Prepare, coordinate, lead and author, all aspects of regulatory submissions (e.g., clinical / marketing submissions, annual reports, investigator brochures, amendments, briefing book for health authority meetings, responses to health authority information requests, adverse event reporting) with internal and external cross-functional teams. Act as the functional Regulatory Affairs expert on project teams, providing regulatory strategy and guidance through all phases of development. Review nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols / study reports, investigator brochures, CMC information / data) and contribute to content as related to regulatory oversight and guidance. Collaborate with cross-functional teams (e.g. Clinical Study Teams, Project Teams, Commercial) and with external business partners such as CROs, consultants, etc. to generate and refine the product development strategy, advise team members of major regulatory issues and provide possible solutions and / or mitigation strategies. Maintain a knowledge of current US and global regulatory requirements to ensure compliance while monitoring and assessing the continued development of the regulatory environment; communicate regulatory updates to inform program strategies. Participate in the external communication reviews along with Commercial, Legal, Medical / Clinical team members in the development of applicable materials. Contribute as a functional Regulatory Affairs expert providing risk assessment of operational deliverables related to health authority guidance documents and organizational goals. Collaborate effectively with Regulatory Operations to ensure quality and content of compliant submissions. Facilitate the compliance to SOPs and work practices governing all phases of the regulatory process Maintain professional working relationships with colleagues, fostering collaboration, and idea sharing to promote highly interconnected corporate operating culture. Contribute to budgets, forecasts, and inquiries for Regulatory Affairs. Qualifications / Skills Bachelor’s degree in a scientific discipline; higher degrees preferred. Minimum of 8+ years of experience in regulatory affairs in pharmaceutical / biotech, (e.g., IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US). Experience interacting with health authorities, leading teams, and strong working knowledge of FDA and / or ex-US regulations. Demonstrated ability to develop strategic regulatory plans, facilitate team decisions, effectively negotiate, and execute strategies in a fast-paced clinical-stage biotech environment. Proven success / major involvement in major submissions and / or approvals. Experience with electronic templates, review and submission technologies, and clinical disclosure portals. Detail-oriented, proactive, and capable of balancing strategic leadership with hands-on execution. Exceptional communication skills for engaging regulatory authorities, senior leadership, and internal stakeholders. Skilled at identifying risks, solving complex regulatory challenges, and implementing proactive mitigation strategies. This is a Remote (work from home) position. Powered by JazzHR
Title :
- Director / Sr.
Director Regulatory Affairs Department :
Create a job alert for this search
Director Regulatory • US
Related jobs
The Physical Therapist provides clinical patient care by initiating and administering appropriate treatment, progressing patient treatment as appropriate, and carrying patient load that reflects pr...Show moreLast updated: 30+ days ago
The Principal Regulatory Affairs position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Cl...Show moreLast updated: 19 days ago
Host Healthcare is seeking a travel Physical Therapist for a travel job in Parsons, Kansas.Job Description & Requirements.
Pay package is based on 8 hour shifts and 40 hours per week (subject to...Show moreLast updated: 30+ days ago
Prime HealthCare Staffing is seeking a travel Physical Therapist for a travel job in Parsons, Kansas.Job Description & Requirements.
Client can take a team : (1 inpatient and 1 outpatient).Treating ...Show moreLast updated: 4 days ago
The Good Life MedStaff is seeking a travel Physical Therapist for a travel job in Parsons, Kansas.Job Description & Requirements.
Physical Therapist (PT) needed for Inpatient Rehab work in a ver...Show moreLast updated: 30+ days ago
Regional Dry Bulk - CDL-A Truck Driver - Earn $68,000 - $83,000 Annually CDL-A Truck Drivers Enjoy : $68,000 - $83,000 yearly earnings $1,300 - $1,600 average weekly pay $200 orientation pay $120 / da...Show moreLast updated: 8 hours ago
Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients.Our science and risk-based compliant quality culture is both flexible and innova...Show moreLast updated: 1 day ago
Why work for Cura Hospitality?.We share an appetite for growth which drives all of us to continually reimagine our customers’ experience.
We are looking to add an experienced .Part-Time C...Show moreLast updated: 2 days ago)
ABOUT CRITICAL PATH INSTITUTE (C-.Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, co...Show moreLast updated: 30+ days ago
TRS Healthcare is seeking a travel Occupational Therapist for a travel job in Neodesha, Kansas.Job Description & Requirements.
TRS Healthcare Job ID #1329416.Pay package is based on 8 hour shifts an...Show moreLast updated: 30+ days ago
Nationwide Therapy Group is seeking a travel Occupational Therapist for a travel job in Neodesha, Kansas.Job Description & Requirements.
About Nationwide Therapy Group.NTG is a proud partner wit...Show moreLast updated: 30+ days ago
The Good Life MedStaff is seeking a travel Occupational Therapist for a travel job in Neodesha, Kansas.Job Description & Requirements Specialty : Occupational Therapist Discipline : Therapy Start Dat...Show moreLast updated: 9 days ago
MedPro Healthcare Allied Staffing is seeking a travel Occupational Therapist for a travel job in Neodesha, Kansas.Job Description & Requirements Specialty : Occupational Therapist Discipline : Therap...Show moreLast updated: 11 hours ago
Do you know why Domino's Pizza hires so many drivers? Well, aside from the fact that our delicious pizza is the perfect solution for dinner for families all across the nation - we do it because we ...Show moreLast updated: 30+ days ago
Company Overview IE is a Consumer Healthcare Technology and Pharmaceutical Launch Partner dedicated to accelerating safe access to life-changing treatments.
Our notable roster of clients comprises h...Show moreLast updated: 30+ days ago
Summary This position is responsible for leading Gan & Lee Pharmaceuticals’ regulatory affairs activities in the U.This role oversees strategy development, submissions, and compliance wit...Show moreLast updated: 30+ days ago
Medical Solutions Allied is seeking a travel Physical Therapist for a travel job in Parsons, Kansas.Job Description & Requirements.
We’re seeking talented healthcare professionals whose ad...Show moreLast updated: 30+ days ago
TRS Healthcare is seeking a travel Occupational Therapist for a travel job in Neodesha, Kansas.Job Description & Requirements.
TRS Healthcare Job ID #1329416.Pay package is based on 8 hour shift...Show moreLast updated: 30+ days ago
- Promoted
Therapist / Physical Therapist / Oklahoma / Physical Therapist in Oklahoma (Sign-on Bonus / Relocation
K.A. Recruiting, Inc.Chelsea, OK, USFull-time +1
Principal Regulatory Affairs Specialist
InogenRemote, USRemote
Full-time
- Promoted
Travel Physical Therapist
Host HealthcareParsons, KS, USFull-time
- Promoted
Travel Physical Therapist - $2,846 per week
Prime HealthCare StaffingParsons, KS, United StatesFull-time
- Promoted
Travel Physical Therapist
The Good Life MedStaffParsons, KS, USFull-time
- Promoted
- New!
Regional CDL-A Truck Driver
Bulk Transport CompanyThayer, KS, USFull-time
- Promoted
Regulatory & Medical Affairs Associate
PfizerUSPermanent
- Promoted
Part-Time Registered Dietitian
Cura-HospitalityCherryvale, KS, USPart-time
Director of Pharmacometrics
Critical Path Institute (C-Path)USAFull-time
Quick Apply
- Promoted
Travel Inpatient Rehabilitation Occupational Therapist - $2,427 per week
TRS HealthcareNeodesha, KS, United StatesFull-time
- Promoted
Travel Occupational Therapist
Nationwide Therapy GroupNeodesha, KS, USFull-time
- Promoted
Travel Occupational Therapist - $3,076 per week
The Good Life MedStaffNeodesha, KS, USFull-time
- Promoted
- New!
Travel Occupational Therapist - $2,646 per week
MedPro Healthcare Allied StaffingNeodesha, KS, USFull-time
- Promoted
Delivery Driver(0638) - 100 N 25th, Independence, KS
Domino's PizzaIndependence, KS, USFull-time
Senior Director of Regulatory Affairs
Idea Evolver(Multiple States), USFull-time
Quick Apply
Regulatory Affairs VP
Gan & Lee PharmaceuticalsUSFull-time
Quick Apply
- Promoted
Travel Physical Therapist
Medical Solutions AlliedParsons, KS, USFull-time
- Promoted
Travel Inpatient Rehabilitation Occupational Therapist
TRS HealthcareNeodesha, KS, USFull-time