Regulatory Strategy Associate: INDs, Submissions & Guidance
$71k11 Premier Research International LLC
11 Premier Research International LLC is seeking a Regulatory Strategy Associate to support our Regulatory Affairs team. This role involves preparing IND Modules and assisting in regulatory submissions while ensuring compliance with all relevant regulations. The ideal candidate will have a Master’s degree or higher with at least 3 years of experience in the CRO or biotechnology sectors. Strong organizational and communication skills are essential, as well as the ability to manage multiple projects simultaneously. We offer a starting salary of $71,000.00 USD and a comprehensive benefits package. #J-18808-Ljbffr
$71k
...Premier Research is looking for a Regulatory Strategy Associate to join our Regulatory Affairs... ...Responsibilities Independently prepare IND Modules for routine submissions. Support regulatory affairs... ...with applicable regulations and guidance and client strategic intent,...Suggested$140k - $185k
...Science Foundry. The Senior Regulatory Specialist will serve... ...global regulatory strategies for our medical device... ...coordinate regulatory submissions including IDEs, 510(k)... ...into actionable guidance for cross‑functional teams... ...meetings (e.g. Pre‑Subs, Pre‑IND, etc.) Strong...SuggestedFull timeLocal areaRemote workFlexible hours- ...with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish...Suggested
$228k - $245k
...The Director, Global Regulatory Affairs will play a critical... ...regulatory strategies to support the global... ...Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs, MAAs, etc... ...programs. Provide regulatory guidance and support to cross-functional...SuggestedFull timeSummer workWork at officeRemote workRelocation packageMonday to Friday- ...A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.D. in Biomedical... ...collaborate with R&D teams, shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific...SuggestedRemote workFlexible hours
- ...Grifols, S.A is seeking a Regulatory Affairs Specialist to manage regulatory documents and compliance at their Vista... ...for deviation reports and assisting with FDA submissions. This position requires an Associate's degree, advanced computer skills in Microsoft Office...Work at office
$148.55k - $174.77k
## Senior Regulatory Affairs SpecialistApplylocations: California -... ...’ll be providing regulatory guidance to cross-functional partners... ...developing global regulatory strategies for new and modified Class... ...preparing and submitting regulatory submissions in the US, EU and outside of...$50 - $67 per hour
...range $50.00/hr - $67.00/hr Sr. Regulatory Specialist Fully remote in... ...and reports under the guidance of the VP, Quality & Regulatory... ...is a key contributor to FDA submissions (PMA/510(k)) and requires excellent... ..., carryover, controls strategy) and author clear, submission...Contract workRemote work- ...Life Sciences Senior Regulatory Affairs Manager 12-month... ...Regulatory Strategy Development Lead the development... ...precedents and regulatory guidance. Provide proactive and... ...programs. Regulatory Submissions and Related Activities... ...interactions. IND/CTA Activities Lead planning...Contract workRemote work
$100k - $200k
...Opportunity**This **Principal International Regulatory Operations Specialist** will work on-... ...Coordinate with regional RA to update submission strategies and registration maintenance in... ...by facilitating training and providing guidance to peers on new/updated requirements**...Worldwide$100k - $137k
# Associate Director, Regulatory Affairs, Marketed Products PortfolioGE HealthCareBe... ...role drives regulatory strategy and execution for new product... ...teams, ensuring timely submissions, approvals, and compliance... ...marketed products, including INDs/CTAs, Clinical Study...Full timeVisa sponsorshipWork visaRelocation package- ...Engineer (Civil), serves as a Program Coordinator in the Mobility Strategies Branch. The incumbent provides support for the branch’s core... ...include developing and maintaining statewide policies, guidance documents, manuals, and strategic plans to assist district traffic...Permanent employmentFull timeTemporary workWork at officeWeekend work
$75.2k - $112.8k
...voice is heard and every story matters. Specialist II, Regulatory Affairs Prepare submissions to obtain and maintain approvals for conducting clinical... ...and reviewing documentation for compliance under guidance from senior staff. Assist in preparing regulatory submissions...Temporary workRemote workWorldwideFlexible hours- ...Description The Director Regulatory Affairs, Device is responsible... ...to support and drive strategy for regulatory submissions, including new... ...changes of regulations and guidance. Interfaces with outside... ...regulatory agencies and trade associations and provides management with...Worldwide
$47.84k - $62.4k
...vision and strategic development and execution of our franchise strategy, creative tools and marketing plans to cultivate brand growth... ...Franchise Strategy Operations Director per their direction and guidance: Supports the annual franchise planning processes and timelines...Work experience placementShift work- ...Power Shutoff) programs Experience with regulatory reporting or regulatory filings... ...implemented enhanced wildfire prevention strategies and strengthened its electrical infrastructure... ...Vice President level. Provide guidance on program design, implementation, and...Remote work
- ...Outreach (35%) Collaborate with internal teams to ensure consistent guidance and communication Engage with local, state, and federal... ...Provide technical expertise related to decarbonization strategies Support development and improvement of statewide building energy...Local area
- ...Termination Analyst in the Secretary of State's office. This Analyst I position involves reviewing campaign termination submissions and providing guidance to stakeholders while ensuring compliance with the Political Reform Act. The successful candidate will demonstrate...Work at officeRemote work
$157.59k - $203.94k
...Senior Manager, CMC Regulatory Affairs for Biologics Responsibilities... ...authorizations, and original INDs/CTAs and NDAs/MAAs for assigned... ...). Contribute to regulatory strategy and solutions for CMC... ...independent completion of routine submissions. In‑depth knowledge of global...$135.1k - $225.1k
...commercial, medical/clinical, regulatory, legal, and HR teams to... ...providing pragmatic, risk‑based guidance on commercial and... ...engagement models and market access strategies. You will manage periodic compliance... ...capture, validation, and submission of reportable HCP transfers...Home officeFlexible hours- ...Bilingual Associate Manager, Regulatory Affairs Merck (6-Month Contract) Location: Kirkland, Quebec Hybrid Position Overview The Associate Manager... ...preparing, filing, and ensuring compliance of regulatory submissions for veterinary products in Canada. This role supports...Contract work
- 6AM City, LLC is seeking a Strategy Team member in the Global Data Office. This hybrid position focuses on data strategy projects, market analysis, and strategic communications. Candidates should have 2+ years of experience and strong analytical and communication skills...Work at office
$198k - $297k
...Senior Manager role you will define and drive our Services vertical strategy, from identifying growth opportunities to influencing roadmap... ...alignment Translate roadmap priorities into actionable field guidance Identify recurring deal blockers and convert insights into...Local areaRemote workFlexible hours$153k - $230k
...THE ROLE As part of the Commercial Strategy and Transformation team, we are seeking a dynamic, strategic minded and analytically-driven individual to fill the role of Commercial Strategy & Transformation Manager. This person will work closely with Commercial Strategy...Work experience placementWork at office$180k - $275k
Associate, Finance & Strategy, Experiences At Netflix, our mission is to entertain the world. Together, we are writing the next episode - pushing... ...opportunities Self‑starter able to operate with little guidance Experience with Google Suite (Sheets, Slides) is preferred...Hourly payFull timeWork at officeFlexible hours- ...Telework is discretionary and based on Caltrans policy and evolving guidance. In-person attendance may be required based on operational... ...through CalCareers.ca.gov, or by mail for hard copy submissions. See the posting for the required documents and formats. If submitting...Work experience placementWork at officeRemote workWeekend work
$114k - $228k
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) page is... ...creating robust global regulatory strategies, working with cross-... ...support for compiling regulatory submissions, and ensuring data is... ...strategic input and technical guidance on regulatory requirements in...Shift work- Lead Engineering, Regulatory, Quality and Clinical Affairs Recruiter... ...global regulatory submissions and ensuring compliance for... ...developing and executing regulatory strategies for both new product introductions... ...teams, offering expert guidance on regulatory requirements,...Full time
$95k
...FUSE is seeking an Executive Fellow to establish a countywide strategy in California's Fresno County, focusing on aligning health, education, and workforce systems. This two-year fellowship will involve substantial collaboration with various stakeholders. The fellow will...- ...compliance with U.S. and foreign trade regulations and develops strategies to mitigate risk and enhance efficiency in international trade... ...ensure compliant supply chain practices. Provide training and guidance to employees on global trade compliance requirements....Full timeFixed term contractWorldwide
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