Remote 505(b)(2) NDA Regulatory Strategist
Pharmatech Associates
- Remote job
A leading regulatory consultancy seeks a highly experienced Regulatory Consultant to guide strategy and manage 505(b)(2) NDA submissions. The role requires at least 10 years of experience in regulatory affairs, specifically with FDA regulations and regulatory strategy development. This fully remote position is ideal for individuals with a strong background in global regulatory applications and excellent communication skills. Join a professional and inclusive team dedicated to ensuring successful product approvals for the pharmaceutical industry. #J-18808-Ljbffr Pharmatech Associates
- ...Associates, Inc. is seeking a highly experienced Regulatory Consultant in the San Francisco area. The role focuses on 505(b)(2) NDA submissions and requires deep FDA regulatory... ...strategy and submission execution, with remote work options available. You will lead regulatory...Remote jobRegulatory
- ...around the world. We are seeking a highly experienced Regulatory Consultant with deep expertise in 505(b)(2) NDA submissions to guide our regulatory strategy and ensure successful product approvals, this role is remote. Job Duties Work closely with Pharmatech and our...Remote workRegulatoryLocal area
- The FDA Group seeks an experienced NDA Regulatory Strategy Consultant to provide senior-level strategic support during the final stages of NDA preparation for a life sciences organization. This remote, part-time role focuses on ensuring the submission is complete, consistent...Remote jobRegulatoryPart time
- ...Responsibilities The Senior Director of Regulatory Affairs is responsible for establishing regulatory... ...have the capability to implement 505b (2) strategies and submissions, a strong... ...record of submissions and approvals of ANDA/NDA (505B2) applications to the FDA. A...RegulatoryWork at office
- ...Job Description Job Description NDA Regulatory Strategy Consultant Location: Fully Remote Work Arrangement: Remote Start: Late Q4 2026 / Early Q1 2027 Schedule: Approximately 20 hours per week Position Overview We are seeking an experienced NDA...Remote workRegulatoryPermanent employmentInterim role
$91k - $145k
Position: Quantitative Strategist - Balance Sheet Strategy & Financial... ...and optimize the consumption of regulatory capital and other scarce... ...model governance standards (SR 26-2).Support interactions with Model... ...varying opportunities for remote work depending on the nature of...Remote workRegulatoryFull timeWork at officeLocal areaWorldwide- EXALTA Group is seeking a Regulatory Specialist 2 to serve as SME in global medical device regulations. This role focuses on regulatory strategy, submissions, labeling, and quality system alignment to ensure compliance and product safety. The candidate will collaborate...Remote jobRegulatory
- Pharmatech Associates is seeking a Regulatory Affairs Consultant to support multiple projects on a remote basis, approximately 10-20 hours per week. The role centers on... ...for pharmaceutical/biotech products across NDA, ANDA, IND, and BLA filings. The ideal candidate...Remote jobRegulatoryPart time10 hours per week
- BBG Ventures, LLC is seeking a Senior Regulatory Affairs Specialist to join their team in Sunnyvale, CA on a hybrid basis (3 days on-site, 2 days remote). The ideal candidate will have a minimum of 8 years of regulatory affairs experience in the medical device sector and...Remote workRegulatoryFor contractors
$112k - $236k
...and here’s how the Director, Regulatory Strategist role will make an impact:Developing... ..., annual reports, IND, NDA, MAA, etc.) meet business needs... ...qualifications for this role are:B.S. Scientific Degree required.... ...-required to be the DC office 2 days per week.Proficiency in...RegulatoryFull timeWork at officeLocal areaWorldwide2 days per week- VB Spine is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for US, EU, and global markets. You will collaborate... ...to enable market approvals and maintain registrations. With 2+ years in FDA-regulated medical devices, you will manage 510(k)...Remote jobRegulatory
- Exalta Group is seeking a Regulatory Specialist 2 to lead regulatory strategy and global submissions for medical devices. The role requires interfacing with product development, quality, and manufacturing teams to ensure compliance across labeling, promotions, and documentation...Remote jobRegulatory
- ...Job43 – EITS Security Risk Analyst B (Engagement) Location: 100% Remote Max Submissions: 5 Proposed Start... ...(SME) on information security and regulatory compliance. Key Responsibilities... ...Data Privacy Investigation Minimum 2 years in a supervisory capacity ?...Remote workRegulatoryImmediate startFlexible hours
$50k - $75k
...Full-time | Remote within approved U.S. states Headquartered in Newtown, Pennsylvania... ...Role We are seeking a Paid Media Strategist with 2–3 years of agency experience to... ...Familiarity with medical, legal, and regulatory review processes. Google Ads, Microsoft...Remote workRegulatoryFull time- ...clients navigating complex policy and regulatory challenges. Our team of seasoned... ...talented and experienced Digital Strategist to join our Strategic... ...work. Officeplace is hybrid, with 1-2 days a week available to work remote if desired. Actual title and salary...Remote workRegulatoryCasual workAfternoon shift2 days per week1 day per week
- ...influencers from Congressional, Executive and Regulatory offices, trade associations, think tanks... ...including on-screen reading and typing; (b) participating in digital/virtual... ...Hybrid with some in-office expectations or remote (as appropriate) Some travel required #J...Remote jobRegulatoryWork at officeWorldwide
$50k
Sr. Litigation Specialist -Remote California - Home Teleworkers Alabama - Home Teleworkers... ...of claims experience with a minimum of 2-4 years Senior Casualty role experience... ...Extensive understanding of statutory and regulatory requirements and ability to develop proficiency...Remote jobRegulatoryHourly payH1bLocal areaWork from homeFlexible hoursWeekend work$161.4k - $282.5k
Lead Product Strategist, Insurance Rating & Pricing Position Description... ...externally. This role is remote within the United States.... ..., pricing strategies, and regulatory requirements Translate complex... ...formal complaint or charge, (b) in furtherance of an...Remote workRegulatoryLocal areaWorldwide- Iterative Health is seeking a Senior Clinical Regulatory Specialist to support compliant execution of Phase 2-4 industry-sponsored trials across our clinical research network. You will provide regulatory guidance and oversight from start-up to closeout, partnering with...Regulatory
$100.01k
...opportunity for a Project Manager 2 position.WORK SCHEDULE100% FTE... ...- Position is primarily remote, but will require onsite work in... ..., 100% immediately vesting 403(b)PRIMARY JOB RESPONSIBILITIESResponsible... ...solution and platform for regulatory, quality, clinical, and business...Remote workRegulatoryFull timeTemporary workWork at officeImmediate startShift workWeekday work- ...experienced and highly motivated Global Regulatory Labeling Lead to provide strategic leadership... ...in biotech/pharmaceutical industry; 2+ years in global labeling/regulatory with... ...environment. #LI-LB1 #LI-REMOTE EEO Disclaimer...Remote workRegulatoryWork at officeLocal areaWorldwide
- ...Astellas is seeking a senior Regulatory Affairs professional based in Northbrook, IL, with global experience and a track record in NDA/IND strategies. You will lead submissions, interact with the FDA and health authorities, and guide cross‑functional teams through complex...Remote jobRegulatory
$189k - $246k
Travere Therapeutics is looking for a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for Phase 2 and Phase 3 development programs. This role involves close collaboration with cross-functional teams and requires significant experience...Remote jobRegulatory- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy responsible for developing and executing regulatory strategies for Phase 2 and Phase 3 programs. This role requires extensive interaction with FDA and global health authorities. Ideal candidates will...Remote jobRegulatory
- Travere Therapeutics is seeking a Director, Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 programs. You will work closely with teams to ensure compliance and strategic alignment with regulatory bodies. The ideal...Remote jobRegulatory
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for Phase 2 and Phase 3 programs. The ideal candidate will lead strategic guidance efforts across various teams, ensuring compliance with regulatory requirements...Remote jobRegulatory
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute global regulatory strategies for Phase 2 and Phase 3 clinical development programs. This role involves close collaboration with Clinical Development and other teams to drive...Remote jobRegulatory
$189k - $246k
Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs. The position requires extensive experience with global health authorities like the FDA and EMA...Remote jobRegulatory- Overview This is a REMOTE position. The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to...Remote workRegulatoryH1bWork at officeLocal areaAfternoon shiftEarly shift
- Travere Therapeutics is seeking a Director of Regulatory Affairs Strategy to develop and execute regulatory strategies for Phase 2 and Phase 3 programs. This position requires a strong leader adept in navigating complex regulatory environments and working closely with cross...Remote jobRegulatory
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