-
Lead Regulatory Affairs Associate
1 day ago
Navitas Life Sciences Trenton, United StatesJob Title: Lead Regulatory Affairs · Work Location: US – EST, CST time zone. · Reports To: Practice Head - Regulatory · Job Description : · Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines · Es ...
-
Regulatory Document Management Lead
1 day ago
Network Partners Group Trenton, United StatesPosition Overview:We are seeking a highly skilled and experienced ETMS Expert to join our team. The ETMS Expert will play a critical role in overseeing the implementation, maintenance, and optimization of our Electronic Trial Master File System. This individual will collaborate w ...
-
Regulatory Document Management Lead
3 days ago
Network Partners Group Trenton, United StatesPosition Overview: · We are seeking a highly skilled and experienced ETMS Expert to join our team. The ETMS Expert will play a critical role in overseeing the implementation, maintenance, and optimization of our Electronic Trial Master File System. This individual will collaborat ...
-
Director - Global Regulatory Lead
1 week ago
Novo Nordisk Plainsboro, United States Full timeAbout the Department · Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the f ...
-
Director, GRA CMC Pharmaceuticals, Oligonucleotides
10 hours ago
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Senior Director, GRA Pharmaceuticals
10 hours ago
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Manager, Statistical Programmer
10 hours ago
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Manager, Statistical Programming, Statistical
10 hours ago
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Dialysis Program Manager Registered Nurse
10 hours ago
Fresenius Medical Care Chambersburg, United States Full timePURPOSE AND SCOPE: · Manages the provision of quality patient care in an independent home therapy program while maintaining cost-effective clinical operations in accordance with all legal, compliance, and regulatory requirements and programs. Takes the appropriate actions and ma ...
-
Information Technology Risk Manager
4 days ago
City National Bank Trenton, United StatesOverview: · **INFORMATION TECHNOLOGY RISK MANAGER** · **WHAT IS THE OPPORTUNITY?** · **What you will do** · - Advance the design, delivery, and performance of IT risk metrics and reporting including the Business Impact Assessment, IT Risk Management Framework, and the management ...
-
R&D Digital Health Product Manager
10 hours ago
Takeda Pharmaceutical Trenton, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I subm ...
-
Director, Global Regulatory Lead
1 week ago
Rocket Pharmaceuticals Cranbury, United StatesOverview · Work at ROCKET PHARMA and help cure rare diseases · Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progr ...
-
Sr. Regulatory Associate Lead
1 week ago
Insight Global Somerville, United StatesOur large medical device client is looking for a Sr. RA Lead to join their team and assist with a backlog of projects. This individual will be helping with a portfolio of class III medical devices and helping the manufacturing site with necessary change assessments. They will dra ...
-
Team Leader
1 week ago
BlueSky Innovations Trenton, United StatesJob Offer: Team Leader (m/f/d) Quality Management Vigilance for our client: B. Braun, a leading medical technology company, is looking for a dedicated Team Leader (m/f/d) for Quality Management in the Aesculap division at the Tuttlingen location. If you are an experienced leader ...
-
Clinical Services Associate
1 week ago
Penn Medicine Yardley, United States**Description** · Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration w ...
-
Quality Assurance Compliance Manager
6 days ago
American Breadcrumb Company Levittown, United States**Safety & Quality Assurance Compliance Manager** · The Food Safety and Quality Assurance Compliance Manager supports and drives compliance in the area of Food Safety for the operators and our customers and works with the warehouses, customers, and suppliers, to provide resolutio ...
-
Store Supervisor- Levittown, Pa
1 week ago
TD Bank Fairless Hills, United StatesWork Location: · Fairless Hills, Pennsylvania · Hours: · 40 · Pay Details: · $ $32.75 USD · Line of Business: · Personal & Commercial Banking · **Job Description**: · The Store Supervisor supervises day-to-day team activities to ensure operational excellence and compliance with p ...
-
Novo Nordisk Princeton, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
Director, Global Regulatory Lead - Trenton, United States - Rocket Pharmaceuticals
Description
Work at ROCKET PHARMA and help cure rare diseasesRocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases.
Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline.
We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients.This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator.
In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
Rocket Pharma is seeking an experienced and highly motivatedDirector, Global Regulatory Lead for LAD-I and PKD
, who enjoys a fast paced, dynamic work environment at the forefront of innovation. The Director will be responsible for providing global regulatory leadership in support of the development, registration, and life-cycle management of our innovative gene therapy programs, as well as for the oversight and mentoring of a growing regulatory team.
The responsibilities include providing global regulatory leadership and direction for Rocket's gene therapy products, including developing long and short-term planning of regulatory projects that align with the company's business plan, and developing strategies to ensure effective achievement of regulatory/business objectives.
The individual will be responsible for staying current of the global regulatory environment and assess and communicate impact of changes on business and product development.
The position will report to the Associate Vice President of Regulatory Affairs - Lenti.Responsibilities:
Provides global regulatory leadership in support of the development, registration, and life-cycle management of Rocket's products.
Guides, coaches and manages a team of regulatory professionals to ensure their professional development and advancement.
Provides strategic regulatory direction and mentorship on programs including developing the overall regulatory plan, advising on regulatory requirements for development plans, study designs and marketing approval, conducting risk.
assessments, and managing critical issues and Health Authority interactions.Ensures the successful implementation and execution of regulatory plans to support product approval and commercialization.
Harnesses knowledge of US, EU and ICH regulatory requirements to strategically and operationally resolve regulatory issues impacting development programs to ensure business goals are met.
Builds partnerships with key senior stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
Liaises and negotiates with US FDA, EMA, MHRA and other regulatory agencies as needed for all aspects pertaining to drug development including novel regulatorypathways for the company's gene therapy products, resolution of key regulatory issues and to expedite approvals of products.
Takes a hands-on approach in leading the completion of IND/CTA, NDA/BLA/MAA, and other global submission documents.
Serves as a subject matter expert on relevant global regulations, stays abreast of changes in the global regulatory environment, and assesses impact of changes on
business and product development programs.
Proactively manages critical issues, taking leadership for regulatory contribution.
Supports the development of relevant policies, processes, and SOPs.
Provides regulatory due diligence assessments of new business opportunities as required.
Requirements:
MS, PharmD/PhD Degree preferred
MS degree and 10+ years Pharmaceutical industry experience
5+ years of regulatory filing (BLA/MAA) strategy preferred.
We encourage applicants with strong expertise in CART or LVV, particularly those with multidisciplinary experience and a PharmD or PhD, to apply.
This skill set and educational background may outweigh the requirement for a specific number of years of experience.Extensive hands-on regulatory experience, including managing IND/CTA, NDA/BLA/MAA submissions, lifecycle management, and Extensive experience in interacting with Health Authorities.
Ability to develop and implement complex global regulatory strategies.
Strong scientific foundation, including a strong understanding of gene therapy products and development.
Practical understanding, interpretation, and application of relevant ICH, FDA and EMA guidelines and regulations.
Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively.
communicates issues to internal and external stakeholders, including Senior Management.Ability to think creatively and develop creative solutions.
Ability to prioritize and handle multiple projects simultaneously.
Sense of urgency and perseverance to achieve bringing curative therapies to patients.
Rare disease and/or gene therapy experience is desirable.
A diverse workforce fosters innovation and strengthens Rocket's business.
We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
#J-18808-Ljbffr
