Director, Drug-Device CMC Regulation (Autoinjector)
Neier Inc
Neier Inc. is seeking a Director/Principal Scientist for their Devices and Drug-Device Combinations Regulatory CMC team. This role involves supporting regulatory activities for the company's autoinjector and inhalation products, ensuring adherence to global regulations and managing technical content for submissions. The ideal candidate will bring strong expertise in regulatory compliance related to medical devices and drug delivery systems. #J-18808-Ljbffr
$190.8k - $300.3k
MSD Malaysia is seeking a Director, Drug & Device Combo for remote work based in New Jersey. This role involves... ...Device Regulatory Affairs strategies for autoinjector and inhalation products, ensuring compliance with global regulations. Candidates should possess a strong...SuggestedRemote work- Associate Principal Scientist, Regulatory CMC - Biologics (R4) Responsibilities Implement Chemistry, Manufacturing, and Controls (... ...product franchises in accordance with domestic and international regulations and guidance. Prepare and submit CMC sections for commercial or...Suggested
$200k
...development opportunities. Position Summary The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and... ...requirements and guidelines Expert knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies...SuggestedTemporary workMonday to FridayFlexible hours$142.4k - $224.1k
...This position is in our organization's Device Development & Technology (DD&T) group in our... ...Engineering (or related field) with 10+ years of regulated industry experience and increasing responsibility in medical devices and/or drug-device combination products. Required...SuggestedFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
Job Overview This position is within the Device Development & Technology (DD&T) group in our Research division. It supports the development... ...Engineering, or a related field with a minimum of 6 years of regulated industry experience. Required Skills and Responsibilities Hands...Suggested$142.4k - $224.1k
...in the Manufacturing Division, specifically within the Biologics Drug Substance Commercialization (BDSC) team. Our Downstream... ...around the world. The Associate Principal Scientist (Associate Director) provides technical and scientific leadership to advance late-stage...Full timeContract workFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$129k - $203.1k
Job Description The Associate Director Quality Systems & Compliance within Device Quality & Regulatory will support our... ...other Global Health Authority Regulations. Accountable for other Quality Programs... ...experience including Regulatory CMC, Quality, development,...For contractorsLocal area- Overview Title: Associate Director of Regulatory Affairs -... ...required for marketed drug products in eCTD format... ...assessment of CMC change controls. For changes... ...with relevant laws and regulations. Lead the implementation... ...changes for drugs, medical devices and dietary supplements...
$173.2k - $272.6k
Director, Oral Formulation SciencesSkip to main content*This site uses cookies... ..., and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the benchtop... ...chemistry, manufacturing and control (CMC) and commercial marketing,...For contractorsLocal areaRelocationVisa sponsorshipFlexible hours$173.2k - $272.6k
...developing, and scaling‑up formulation, device, and manufacturing processes. Overview The Director of Oral Formulation Sciences will... ...advanced knowledge of oral drug product development to the... ...chemistry, manufacturing and control (CMC), and commercial marketing to balance...RelocationVisa sponsorship$142.4k - $224.1k
...combination products? Join our company's Device Development & Technology (DD&T) Team,... ...and commercialization of novel biologic/drug/vaccine-device combination products for safe... ...device technologies, relevant worldwide regulations, standards, and effectively share this knowledge...Local areaWorldwideVisa sponsorship$142.4k - $224.1k
...Job Description The Associate Director, Regulatory Affairs, supports products in the Oncology... ...applications, investigational new drug (IND) applications, pediatric plans and annual... ...Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g.,...For contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$167k - $210.3k
...Description Summary: The Associate Director, US Marketing, is responsible for the development... ...compliance with all corporate policies, regulations, and laws. Develops and supports... ...orphan, rare disease and/or specialized drug(s) that requires the development and...Temporary workWork at officeLocal area$173.2k - $272.6k
...leader is responsible for providing Antibody Drug Conjugate (ADC) expertise and supporting... ...Practices (cGMPs), other worldwide regulations and our company's requirements. Primary... ...divisions' Quality departments and Technical CMC teams for end-to‑end Quality oversight/support...For contractorsWorldwide- ...on quality oversight for large molecule drug substance process & analytical development... ...of clinical supplies.The **Associate Director, Quality Assurance BVDQ** is responsible... ...compliance with cGMPs, applicable worldwide regulations, and our company's requirements for...Worldwide
$173.2k - $272.6k
...small molecule development pipeline. The PAS Director provides strategic and operational... ...release, and support stability for clinical drug substance and drug product. This role partners... ...process and formulation development, CMC and Regulatory, Quality, and manufacturing...For contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...small molecule development pipeline. The PAS Director provides strategic and operational... ...release, and support stability for clinical drug substance and drug product. This role partners... ...with process and formulation development, CMC, regulatory, quality, and manufacturing/...$173.2k - $272.6k
Merck & Co. is seeking a Director of Oral Formulation Sciences in Rahway, New Jersey. This role involves leading a team of scientists and engineers in the formulation and process development of oral product pipelines. The individual will drive program strategy and execution...Relocation package$156.9k - $247k
Director Packaging and Assembly Platform Technical Leadership Responsibilities Lead, mentor... ...to ensure compliance with relevant regulations and standards. Qualifications Bachelor... ...fields Subject matter expertise in medical device and combination product...For contractorsWork at officeRemote work3 days per week$60k - $65k
...to recruit, hire and retain highest quality Security Agents. ~ Disciplines Agents as necessary. ~ Maintains all provisions, regulations, procedures and processes in current collective bargaining agreement. ~ Performs all other duties as assigned by ACTS-Aviation...Local areaImmediate startShift work- ...experience ~ Knowledge of federal and New Jersey labor laws and regulations ~ Experience with HRIS systems and payroll platforms Key... ...screening. Details: Applications are accepted on an ongoing basis. Levy maintains a drug-free workplace. Compass GroupLocal areaRemote workFlexible hours
$117k - $184.2k
...Supervisor position will report to the Associate Director, MACS Operations and will be a member of... ..., macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical... ...GDPs), and Safety & Environmental (S&E) regulations. Experience operating/maintaining...For contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift workNight shiftDay shiftAfternoon shift- ...appeals, mediations, settlement agreements, conflict resolution, and drug and alcohol programs. What you will bring: Required... ...EEO laws and other employment related state and federal laws & regulations. ~ Demonstrated ability to work under pressure and deal with...Live inWork at officeFlexible hours
$70k - $100k
...a trusted advisor to employees and managers to resolve workplace issues effectively. Ensure adherence to U.S. labor laws and regulations, including federal and state employment requirements. Maintain up-to-date knowledge of compliance standards and implement HR policies...Full timeWork at officeVisa sponsorshipWork visa- ...to the Vice President of Human Resources, the Human Resources Director provides comprehensive human resource related support to our 5... ...outcomes Strong knowledge of employment-related local/state/federal regulations Knowledge of Word, Excel, PowerPoint, Visio, HRIS/ADP...Seasonal workWork at officeLocal areaRemote work2 days per week3 days per week
- ...chart below for the salary range for the corresponding location. FINRA complies with all state and local pay transparency laws and regulations requiring the disclosure of salary ranges for the position. In addition to location, actual compensation is based on various...Full timeTemporary workFor contractorsWork experience placementFor subcontractorLocal areaImmediate start
$60 - $75 per hour
...Job Description: Medical Device Industry Rate: $60 to $75 Location: US Remote/hybrid... ...includes the enabling of translating drug development requirements into the consequences... ...on Medical Devices and diagnostics regulation-aware critical thinking about the pharmaceutical...Remote work- Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC Company: Merck & Co. Location: Rahway, NJ. Job Description: Global Regulatory... ...pipeline products in accordance with global regulations and guidance, with a focus on small molecule respiratory...
$310k
...Department of Pathology and Laboratory Medicine, are seeking a Director (Chief) for the Division of Anatomic Pathology. This leadership... ...strongly encouraged to apply Benefits · Medical, prescription drug, and dental coverage · Paid vacation, holidays, and various...$139k - $232k
...Radiation Safety Officer (RSO) Associate Director provides Environmental, Health, and... ...and New Jersey Radiation Protection Code) regulations and Lantheus' standards. The RSO Associate... ...package that includes medical, prescription drug, dental, and vision coverage. Other...For contractorsLocal areaImmediate start
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