Senior Regulatory Director, Infectious Disease Biologics
Tonix Pharmaceuticals
Tonix Pharmaceuticals seeks a Senior Director of Regulatory Affairs for Infectious Disease to drive global regulatory strategy across biologics and vaccines from early development through initial product registration. You will lead health authority interactions, coordinate cross-functional teams, and shape development plans while navigating complex regulatory pathways in a fast-paced biopharma environment. #J-18808-Ljbffr Tonix Pharmaceuticals
$200k - $275k
Senior Director, Regulatory Affairs - Infectious Disease Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central... ...candidates are investigational new drugs or biologics; their efficacy and safety have not been established...SeniorTemporary workLocal areaFlexible hours- Tonix Pharmaceuticals is seeking a Senior Director, Regulatory Affairs for Infectious Disease to lead global regulatory strategy from early development through product registration. This senior role requires strategic thinking, strong FDA experience, and the ability to...SeniorWorldwide
$108k - $176k
Manager, CMC Regulatory Affairs - BiologicsAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, CMC Regulatory Affairs - Biologics to join our CMC Regulatory Affairs team, supporting our...SuggestedFull timeWorldwide$121.35k - $180.85k
...all backgrounds. We are seeking a talented and motivated Senior Manager or Associate Director, Compliance Americas & UK to join our team. This role... ...support Compliance Fraud waste and abuse Compliance and regulatory requirements for the corporate organization. This role...SeniorWork at office$120k - $145k
...products Batch record reviews, as required Qualifications Bachelor of Science required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology) Minimum 10 years’ experience in the pharmaceutical industry with focus...SeniorFull timeContract workFlexible hours- Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content. The position requires...Senior
- Rutgers University in New Jersey seeks a Research Associate III in the Biochemistry & Molecular Biology department at RWJ Medical School to perform technical research on polymerases, helicases, and proteases under a faculty supervisor. The role includes protein-ligand interaction...Senior
- ...related to product under development. Preparation, submission, and monitoring of PLAIR activities, prior to new product launch Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions. Provide...SeniorLocal area
- ...BioSciences, LLC in the United States seeks a Senior Manager External Manufacturing... ...performance to ensure reliable supply of biologic drug substance and product. You will partner... ..., Quality, MSAT, Supply Chain, Regulatory, CMC Development, Procurement, Legal, and...Senior
$145k - $165k
.... About the Role The Regulatory Affairs Manager is responsible... ...close collaboration with the Director of Regulatory Affairs, the... ...recommendations, and risk evaluations for senior management to support... ...in Pharmacy, Chemistry, Biology, or related field required....Full timeFlexible hours$140k - $200k
Overview The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing... ...CMC requirements for advanced therapies and/or biologics across the product lifecycle, including development,...SeniorFull timeWork at officeLocal area- Shionogi Inc. seeks a Director, Trade Accounts in New Jersey to lead enterprise-wide trade and distribution strategies for Infectious Diseases and Rare Diseases. You will manage key trade relationships, negotiate distribution agreements, and partner with Finance, Supply...Senior
- Shionogi Inc. in Florham Park, NJ, seeks a Senior Manager, Regulatory Affairs CMC to lead strategy and coordination of CMC regulatory activities under the Senior Director, CMC. You will partner with R&D, QA, manufacturing, and regulatory authorities to ensure compliant...Senior
- ...practices are implemented. The ideal candidate is passionate about biological sample testing, possesses strong organizational, communication,... ...listed below Scientist 3 - B.S. with 3-5 years of experience Senior Scientist I - B.S. with 5+ years of experience...SeniorFull timeWork at office
$210.4k - $331.1k
Job DescriptionThe Senior Director, Clinical Science, Infectious Disease is responsible for providing strategic Clinical... ...Disease, including disease biology, current and emerging treatment... ...collaboration with Clinical Operations, Regulatory Affairs, Biostatistics and Data...SeniorFull timeFor contractorsLocal areaFlexible hours$117k - $184.2k
...innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough.Biologics Process Research & Development (BPR&D) within our Research & Development Division is on a mission to rapidly deliver diverse...SeniorFull timeFor contractorsLocal areaFlexible hours$180k - $210k
...) for the prevention of Lyme disease in the U.S., and TNX-1500, a... ...investigational new drugs or biologics; their efficacy and safety have... ...Position Overview The Director, Compliance reports to the VP... ...meets or exceeds applicable regulatory standards for effective compliance...Temporary workWork at officeLocal areaFlexible hours$98 - $100 per hour
...Global Regulatory CMC Manager Location: 50% onsite at Giralda Farms, NJ, 07940 Duration... ...Development Operations (CTDO). The GRS-CMC Senior Manager II will assess Manufacturing... ...advanced therapies and/or small molecules, biologics, cell therapy during development and...Hourly pay$170k
...immune system to defeat cancers and infectious diseases. The Company's range of... ...Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible... ...attention to detail Knowledge of Biologic-based drugs including cell-based...Temporary workMonday to FridayFlexible hours$190.8k - $300.3k
Job DescriptionOur Regulatory Affairs team in General Medicine advances... ...and professionalism.The Senior Principal Scientist, Regulatory... ...investigational and marketed drugs/biologics in early- and/or late-stage... ...to:Report to Executive Director or Associate Vice President,...SeniorFull timeFor contractorsLocal areaWorldwideFlexible hours- Role Associate Principal Scientist/Associate Director in Regulatory CMC focusing on biologics conjugates, primarily ADCs and bio-conjugates, with responsibilities spanning global regulatory strategy development, dossier preparation, and lifecycle management for synthetic...
- Job title: Senior Manager Regulatory Affairs Advertising and Promotion Location: Morristown, NJ/Cambridge, MA About The Job As the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting...SeniorWork experience placement
$90k - $200k
...Senior Manager, Financial Investigations Kroll's North American Investigations, Diligence and Compliance practice is seeking a Senior... ...a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client)...SeniorTemporary workFlexible hours$187.7k - $227.45k
...prevail over serious diseases. We offer uniquely interesting... ...Summary The Director, Quality Compliance at... ...significant quality events to senior leadership; authoring... ...notifications (e.g. Biological Product Deviation... ...Systems, validation, and regulatory. Proven experience...Hourly payFull timeSummer workLive inLocal areaRemote workFlexible hours- ...Senior Manager Regulatory Affairs position focused on developing and executing US and Canada regulatory strategies for marketed and developmental... ...policies Requirements Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field Minimum 6...Senior
- Kalaris Therapeutics, Inc. in Berkeley Heights, NJ, seeks a Director/Senior Director, Drug Product Development to lead strategic and technical development of an intravitreal Fc-fusion biologic from Phase 3 through commercial launch. This role oversees formulation development...Senior
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- ...YouTube. Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion-... ...professionals as needed. Supports the Director in efforts to influence the regulatory... ...: Bachelor’s degree in science (biology, chemistry, microbiology immunology,...SeniorFull timeWork at officeLocal areaRemote work
- ...YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada... ...Regulatory Lead (GRL), Associate Director, or Director), in the development & execution... ...: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry...SeniorFull timeWork at officeLocal areaRemote work
$260.3k - $409.7k
...Principal Scientist (Clinical Director) in Translational Medicine/... ...Development in the Infectious Diseases Therapeutic Area.Translational... ...Phase 3 through to worldwide regulatory applications.Success depends... ...responses to study biological activity in humansProviding...Full timeFor contractorsLocal areaWorldwideFlexible hours
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