Remote Associate Director, Global Regulatory - Biologics
Candel Therapeutics
- Remote job
Candel is seeking an Associate Director, Regulatory Affairs to lead global regulatory strategies for oncology ATMP programs across US, EU, UK, Japan and other regions. You will partner with Clinical, CMC, Quality, Research and Commercial teams, manage regulatory submissions, and navigate ex-US health authorities to enable timely approvals while aligning with risk and compliance frameworks. #J-18808-Ljbffr Candel Therapeutics
$154.4k - $242.55k
...therapies, including ADCs, complex biologics and small molecules. Our goal is to... ...patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part... ...hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workMinimum wageLocal areaWorldwide$135.3k - $202.9k
...development and career advancement across the globe.Scope: The Associate Director, Global Regulatory Affairs Lead is responsible for the regulatory strategy... ...Tuesday-Thursday with Monday and Friday offered as remote flexible.Pay Range for this position: $135,300 - $202,90...Remote workLocal areaMonday to FridayFlexible hours$154.4k - $242.55k
...guidance to teams for the delivery of global regulatory strategies to support development and... ...guidance comments and supporting trade association working groups.Education & Competencies... ...-tailored communicationLocation: Remote within the USTakeda Compensation and Benefits...Remote workMinimum wageLocal area$154.4k - $242.55k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...classified as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda Compensation and Benefits...Remote workMinimum wageLocal areaWorldwide$154.4k - $242.55k
...will inspire you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology... ...within our Global Regulatory Affairs organization, based remotely. Partners with the Global Regulatory Lead (GRL) on...Remote workMinimum wageFull timeLocal areaWorldwide$150k - $210k
...Leveraging our expertise in muscle biology and small molecule drug... ...This position will contribute regulatory CMC experience to Edgewise... ...submission activities for US and global assigned products. The... ...with experience working in a remote environment. ~ Able to adapt...Remote workFull timeFor contractors$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and... ...and/or analytical focus.8+ years of experience in Biologics focused Regulatory CMCMultidisciplinary focus on certain...Permanent employmentFull timeWork at officeWork from home$190k - $240k
...Location Remote Reporting to Executive Director, Regulatory Science Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives... ...experience of development/registration of biologics and/or Advanced Therapy Medicinal...Remote workOdd jobLocal area$142.5k - $256.5k
...The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing... ...and/or analytical focus. ~8+ years of experience in Biologics focused Regulatory CMC Multidisciplinary focus on certain...Permanent employmentWork at officeLocal areaWork from home- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions... ...filings. The successful candidate will bring a strong biologics background, strategic leadership, and the ability to...Remote job
$140k - $170k
...Position: Regulatory Writer (Sr. Manager/Associate Director) Department: Development – Regulatory... ...Affairs Location: Remote (PST Zone) with... ...To: Executive Director, Global Regulatory Affairs P osition... ...Experience supporting biologics development. Experience...Remote workFull timeContract workWork from homeOverseas- ...staffingfuture.comPosition Summary:The Associate Director, Labeling Strategy is... ...developing and executing global regulatory labeling strategies... ...scientific discipline such as Biology, Biotechnology, Biochemistry... ...role is expected to be 100% remote. Comp based one level/...Remote workLocal area
$181.16k - $224.72k
...Associate Director, CMC Regulatory Affairs Job Category : Development - Ionis Requisition... ...our onsite, hybrid and remote work environments a place... ...to establish and execute global CMC regulatory strategies... ...(e.g., chemistry, biological sciences, engineering) required...Remote workFull time$185k - $210k
...Associate Director, Regulatory Affairs The Associate Director, Regulatory Affairs... ...specific emphasis on US and global (Ex-US) regulatory strategy... ...authority expectations for biologic products with novel cell and... ...in a professional or remote office environment and requires...Remote workWork at office- ...Job Title: Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical) Department... ...of Regulatory Location: Remote or Onsite Position... ...& Nonclinical) will lead global regulatory strategy and execution... ...regulatory strategy for biologics or gene therapies and the...Remote work
$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This... ...bring a broad scientific foundation in biologics and/or complex modalities, along with...Full timeTemporary workWork at officeLocal areaFlexible hours$164k - $213k
...Associate Director, Regulatory Affairs CMC At Insmed, every moment and every patient... ...person who joins in. As a global biopharmaceutical company... ...pharmaceutical industry. Biologics and inhalation drug... ...ll Work This is a fully remote role. It can be performed...Remote workTemporary workFlexible hours$165k - $210k
...current limitations of biologic and peptide drugs. We... ...financed by top-tier global life sciences... ...Position Summary:The Associate Director, Global GCP QA is responsible... ...across global regulatory requirements (FDA, EMA... ...location. Role can be REMOTE or ONSITE (if onsite,...Remote workContract work$154.4k - $242.55k
...to shine? Join us as an Associate Director, Separation Sciences, Biologics Analytical Development in... ...work. Certified as a Global Top Employer, we offer stimulating... ...robustness to support regulatory filings,... ...with Takeda’s Hybrid and Remote Work policy.Empowering Our...Remote workMinimum wageWork at officeLocal area$148.5k - $257.4k
...people around the world. We are a global healthcare leader... ...strategic, tactical and operational regulatory CMC leadership across therapeutic... ..., Analytical Sciences, Biology, or similar. ~10+ years of... ...Location: Indianapolis, IN. A remote option may be considered. Relocation...Remote workFull timeRelocation packageFlexible hours$201.8k - $264.8k
...negotiates evidence with regulatory agencies. Interacts... ...approval on of new drugs, biologics/biotechnology and/or... .... As a Regional or Global Regulatory Lead,... ...Thursday). We will consider remote candidates who are... ...salary range for the Director, Global Regulatory Affairs...Remote workWork at office3 days per week$182.07k - $235.62k
...come.Key Responsibilities:The Associate Director, Strategic Sourcing &... ...Management, Sterile Drug Product and Biologics owns the strategic business... ...GFlex program allowing remote work up to 2 days per weekEssential... ...face-to-face meetings with global CMOs; work closely with...Remote workFull timeContract workFor contractorsLocal area- Role: Associate Director, CMC Regulatory Affairs, providing strategic and operational leadership... ...develop and execute global CMC regulatory strategies;... ..., and familiarity with biologics or combination products. High... ...agencies. Work Setup remote with some travel (~10%), onsite...Remote work
$150k - $195k
Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference... .... Position Summary: The Associate Director, Labeling Strategy is responsible... ...discipline such as Biology, Biotechnology, Biochemistry,...Remote workTemporary workLocal area- Associate Director, Regulatory Affairs CMC (Project Management) Job Description Company... ...collaboration with CMC and global development teams, and with... ...biochemistry, chemistry, biology, or related pharmaceutical... ...dynamic workplace that balances remote work flexibility with the...Remote workContract work
$230.4k - $345.6k
...products to our patients and customers. Our global presence provides opportunity for all... ...regard for our employees. The Director, Global Regulatory Strategy Lead will provide strategic... ...regulated pharmaceutical industry (biologics or small molecule) required....Remote workFull timeContract workLocal areaWorldwideRelocation$154k - $215k
...54,000-$215,000 Location: Remote (US) Core hours: Eastern or... ...: Position Summary The Associate Director, Regulatory Affairs will serve as a regulatory... ...maintenance. This is a global role with primary... ...regulatory landscape for biologics, with demonstrated expertise...Remote workLocal areaVisa sponsorshipWork visa$150.5k - $225.7k
...Description General Summary: The Associate Director of Logistics Operations is... ...of all Small Molecule & Biologics product distribution and... ...sourcing & selection activities of global 3PLs that can be used by the... .... Flex Designation: Remote-Eligible Flex Eligibility...Remote workFull timeContract workSummer workWork at officeFlexible hours2 days per week- Title: Associate Director, Global Regulatory Affairs Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical... ...(not limited to Pharmacy, Medicine, Chemistry, Biological Sciences) is required. Language(s) (essential): Fluent...Local areaWorldwide
- ...Job Description Title: Associate Director, Signal Management & Innovation... ...Location: Cambridge, MA 02139 (Remote) Duration: 6+ Months (... ...management activities within a global Patient Safety organization.... ...Pharmacovigilance, Global Regulatory Affairs, Data Sciences, Medical...Remote job
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