Associate Director Regulatory Affairs
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Aspen Neuroscience, Inc. in San Diego, CA, is seeking an Associate Director of Regulatory Affairs (CMC) to lead strategic and operational CMC activities for biologics cell therapies and delivery devices from development through lifecycle management.
This on-site role requires collaboration with cross-functional teams and interactions with global authorities. The candidate will develop regulatory strategies, manage submissions (IND Module 3, IMPD), lead risk assessment, and mentor staff while
#J-18808-Ljbffr- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory...SuggestedWork at officeFlexible hours
$150k - $195k
...science and service for rare patients.Position Summary: The Associate Director, Regulatory Project Manager (RPM) at Travere Therapeutics is responsible for leading and coordinating global regulatory affairs activities to ensure compliance with health authority requirements...SuggestedFull timeTemporary workRemote workShift work- ...provides flexibility to work 4 days at our San Diego site and Friday remotely. Summary of Job Responsibilities The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role includes...SuggestedWork experience placementWork at officeRemote work
- ...kozmetickesluzby.vecnakraska.sk - Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. This role involves developing regulatory strategies for new product submissions and handling...SuggestedRemote workFlexible hours
- ...of delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Associate Regulatory Affairs Manager Location: Onsite - San Diego, CA Position Summary The Associate Regulatory Affairs Manager will support the development...SuggestedFull timeWork at officeFlexible hours
- ...escalating appropriately.Excellent collaboration skills in a cross-functional environment, including Legal-Compliance, Commercial, Medical Affairs, Patient Advocacy, Finance, IT, and external vendors.Strong drafting and editing skills in Word, PowerPoint, Excel, and similar...
- ...: ApplicationsEmail: ****@*****.*** Summary:The Associate Director, Regulatory Project Manager (RPM) is responsible for leading and coordinating global regulatory affairs activities to ensure compliance with health authority requirements. This...Remote workShift work
$210k - $240k
...are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The PositionThe Director of Regulatory Affairs is Arrowhead’s Labeling lead, who drives cross-functional development and execution of global regulatory labeling...$240k - $275k
San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline, supporting programs from early development through registration. This individual...Full timeSummer workWork at officeRemote workRelocationRelocation packageShift work- ...BlossomHill Therapeutics, Inc. is seeking a Director, Regulatory Affairs, onsite in BlossomHill's San Diego office, to lead worldwide regulatory strategies and manage submissions for our clinical programs. In this role you will author and coordinate regulatory documents...Work at officeWorldwide
- ...Artiva Biotherapeutics Inc. is seeking a Director/Senior Director of Regulatory Operations to build and scale regulatory operations for NK cell therapies. This role owns end-to-end submission planning, global filings, and the regulatory information management platform...Remote work
- ...Director Of Regulatory Affairs The Director of Regulatory Affairs (RA Director) will manage, evaluate, and execute regulatory projects consistent... ...the development of product labeling, including USPI and associated patient labeling, and support labeling review and...For contractorsWork at office
$189.7k - $237.1k
...Position Summary Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA; San Francisco, CA; or Princeton, NJ. Primary Responsibilities Manage CMC regulatory affairs for marketed products and compounds in development (US and ex-US). Coordinate with...Work at office3 days per week- ...A biotechnology consulting firm is seeking a Regulatory Affairs Consultant to support projects with about 10-20 hours of work per week. This remote position requires expertise in regulatory strategy development, especially in relation to in-silico modeling. Candidates...Remote work10 hours per week
$209.05k - $249.04k
..., a non‑covalent, pan‑KRAS inhibitor for treatment of diverse KRAS‑mutant tumors. BlossomHill Therapeutics is seeking a Director, Regulatory Affairs, reporting to the Executive Director, Regulatory Affairs, to work with cross‑functional teams to develop worldwide regulatory...Work at officeLocal areaWorldwide$189.7k - $237.1k
...days per week on average Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small... ...world. Primary Responsibilities Manages the CMC regulatory affairs activities for marketed products and compounds in development...Work at officeLocal areaRemote workWorldwideNight shift3 days per week- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...Remote job
$210k - $240k
...intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory Reports to: VP, Regulatory and Quality...Full timeTemporary workInternshipFlexible hours- ...creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera. This position involves...
- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding $101-$200 million...
$64.9 - $67.31 per hour
...operations, medical records regulations, and applicable laws Compliance Officer & Risk Manager opportunity supporting healthcare quality, regulatory compliance, risk management, and culturally responsive patient care. Leads compliance, risk, quality, patient safety, operations,...All shiftsShift workAfternoon shift$150k - $170k
...to bring new therapies to patients in need. The PositionThe Associate Director, Global Strategic Sourcing & Procurement will lead the development... ...protections.Partner with Legal to ensure contracts reflect regulatory, compliance, and IP requirements.Partner with the Corporate...Contract workWork at office$116k - $151k
...forge new paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the...Full timeContract workTemporary workRemote work$170k - $185k
...employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The PositionThe Associate Director, Corporate Financial Planning & Analysis (FP&A) will serve as a key member of Arrowhead's Corporate Finance organization,...Work at office$184.06k - $223.04k
...Manage relationships with key internal stakeholders including regulatory, clinical and commercial and scientific communications and... ...status, please login to your Candidate Home Account.R1605872 : Associate Director, Translational Medicine, NeuroscienceSummaryLocation:...Hourly payFull timeFor contractorsSummer workLive inLocal areaRemote workFlexible hours$127.3k - $178.23k
...diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless!The Associate Director position is an entry level management position that allows team members to develop skills needed to become a Director. The...Full timeLocal area- We are seeking a strategic and experienced Associate Director of Immunology to help drive our efforts in developing drugs for autoimmunity and inflammation, shaping and advancing novel therapeutic programs. This individual will serve as an immunology lead and bring strong...Summer holidayLocal area
$129.2k - $297.85k
...Seramount, Fair360 and others. If you're as passionate about your future as we are, join our team.KPMG is currently seeking an Associate Director, Tax to join our Partner Tax team.Responsibilities:Accountable for the individual income tax compliance, tax counseling, tax...H1bLocal areaWeekend work$190.54k - $230.89k
...patients. Learn more about RayzeBio: RayzeBio is seeking an Associate Director, In‑Vivo Pharmacology to provide scientific and operational... ...accountability for vivarium operations, animal welfare, and regulatory compliance (IACUC/AALAC). This is a highly cross‑functional...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours- ...GroupContact: ApplicationsEmail: ****@*****.*** Associate Director, Corporate Counsel, Legal Contracts is responsible for... ...compliance and enforcement, risk assessment, and legal and regulatory compliance.Resolve legal and compliance issues using...Contract workRemote work
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