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Regulatory Affairs
4 hours ago
The Judge Group Palo Alto, United StatesOur client is currently seeking a Regulatory Affairs for a 12 month + contract.Hybrid position, 2 days in office (Palo Alto, CA).Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to r ...
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Regulatory Affairs Professional
2 weeks ago
Cygnus Professionals Palo Alto, United StatesKnowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches · Product Registration Exper ...
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Regulatory Affairs Specialist
2 weeks ago
Net2Source Inc. Palo Alto, United StatesJob Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension ) · Location: Palo Alto CA Hybrid) · Experience: 5-8 years. · Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in ...
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Regulatory Affairs Specialist
2 weeks ago
Net2source Palo Alto, United StatesJob Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension ) · Location: Palo Alto CA Hybrid) · Experience: · 5-8 years. · Knowledge: · Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how ...
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Regulatory Affairs Specialist
2 weeks ago
Net2source Palo Alto, United StatesJob Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension) · Pay Rate: $68.89/hr. · Location: Palo Alto CA USA 94304 Hybrid · Need Local Candidates to Palo Alto CA · You could be just the right applicant for this job Read all associated informat ...
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Senior Manager Regulatory Affairs
4 weeks ago
Proclinical Staffing Palo Alto, United States PermanentSenior Manager Regulatory Affairs - Remote - Permanent · Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candida ...
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Senior Regulatory Affairs Specialist
1 week ago
CONFLUX SYSTEMS Palo Alto, United StatesHere are the job details for your review: · Job Title: Sr. Regulatory Affairs Specialist · Job Location : 911 Hansen Way, Bldg 3, Palo Alto, CA Hybrid) · Pay Rate: $68.89/HR on W2 · Duration: 12+ Months (Possibility of extension) · Client Name : Siemens · Shift Hours : 8am-5pm · ...
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Senior Regulatory Affairs Specialist
1 week ago
CONFLUX SYSTEMS Palo Alto, United StatesHere are the job details for your review: · Job Title: Sr. Regulatory Affairs Specialist · Job Location : 911 Hansen Way, Bldg 3, Palo Alto, CA Hybrid) · Pay Rate: $68.89/HR on W2 · Duration: 12+ Months (Possibility of extension) · Client Name : Siemens · Shift Hours : 8am-5pm · ...
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Director, Regulatory Affairs, Oncology
3 weeks ago
Ascendis Pharma Palo Alto, United StatesJob Description · Job DescriptionThe Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, wo ...
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Head of Regulatory Affairs, Oncology
1 week ago
Ascendis Pharma Palo Alto, California, United States PermanentWe are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncology. · Guided by our core values of patients, science, and passion, we use our TransCon drug developm ...
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Head of Regulatory Affairs, Oncology
3 weeks ago
Ascendis Pharma Palo Alto, United StatesWe are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncology. · Guided by our core values of patients, science, and passion, we use our TransCon drug developme ...
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Associate Director, Regulatory Affairs
3 days ago
Ascendis Pharma Palo Alto, United States· Are you the right candidate for this opportunity Make sure to read the full description below. · The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the ...
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Associate Director, Regulatory Affairs
3 weeks ago
Ascendis Pharma Palo Alto, United StatesJob Description · Job DescriptionThe Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as requ ...
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Sr. Regulatory Affairs Specialist
2 weeks ago
APN Software Services, Inc Palo Alto, United StatesPlease contact Abdul on "" OR email me at "" · *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · * Identifies, analyzes and implements country specific requirements necessary f ...
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Associate Director, Regulatory Affairs
4 hours ago
Ascendis Pharma Palo Alto, United StatesThe Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. · The RA Associate Directo ...
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Regulatory Affairs Associate
2 weeks ago
Apex Systems Mountain View, United StatesJob#: · Job Description: · Client: IRIDEX · Position: Regulatory Affairs Associate · Location: Mountain View, CA · Estimated Duration: The client approximates that this project may last up to 5 months. However, there is no guarantee of employment for any length of time. · Pay Ra ...
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Regulatory Affairs Specialist
2 weeks ago
Net2Source Inc. Palo Alto, United StatesJob Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension) · Pay Rate: $68.89/hr. · Location: Palo Alto CA USA 94304 Hybrid · Need Local Candidates to Palo Alto CA · Job role required to support tasks for software and VBT projects. · Position Descri ...
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Senior Manager, Regulatory Affairs
3 weeks ago
Meet Recruitment Menlo Park, United StatesSenior Manager, Regulatory Affairs · *Hybrid Role - Menlo Park, CA* · Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage pipeline. They are l ...
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Regulatory Affairs Specialist
4 days ago
Net2source Inc. Palo Alto, United StatesJob Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension )Location: Palo Alto CA Hybrid)Experience: 5-8 years.Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various cont ...
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Head of Regulatory Affairs and Quality
3 weeks ago
Russell Solutions Group Menlo Park, United StatesJob Description · Job DescriptionHead of Regulatory Affairs and Quality · About This Role: · We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he ...
Senior Manager Regulatory Affairs - Palo Alto, United States - Proclinical Staffing
Description
Senior Manager Regulatory Affairs - Remote - PermanentProclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candidates.
Primary Responsibilities:
The successful candidate will be responsible for supporting regulatory strategy, systems, processes, submissions, and health authority interactions. This role requires close collaboration with cross-functional team members within the company.
Skills & Requirements:
In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva RIM and StartingPoint templates).
Strong communication and collaboration skills.
Experience in regulatory affairs within the pharmaceutical/biotechnology industry.
The Senior Manager will:
Support the implementation of the regional regulatory strategy and regulatory submission plans in line with business objectives.
Facilitate tactical implementation at the regional level and contribute to effective communications with regional and global teams on product activities and issues.
Participate in the preparation for meetings with regional regulatory agencies.Support communications with FDA in support of submissions.
Prepare, review, and provide input on documents for submission to regional regulatory agencies.
Collaborate with regulatory team members and functional subject matter experts to build and maintain the content plan for INDs, NDAs, etc.
to ensure timely delivery of submission components.Maintain current IND, ODD, and NDA submissions by ensuring timely and appropriate submission of required information within eCTD sequence as well as maintaining logs.
Contribute to the management of product lifecycle submissions (e.g., DSURs, IBs).If you are having difficulty in applying or if you have any questions, please contact
Nicholas Walker
at
(+1)
or
.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.#J-18808-Ljbffr