Regulatory Affairs Specialist
2 weeks ago
We are seeking a highly skilled Senior Associate, Regulatory Affairs to join our team at Sun Pharmaceutical Industries, Inc. This role will be responsible for preparing, reviewing, and submitting regulatory documents to the FDA, as well as providing regulatory support for post-marketing commercial activities.
Key Responsibilities- Prepare and submit new ANDAs, NDAs, DMFs, and INDs in eCTD format for FDA submission
- Write related module (Mod 1) in CTD format for NDA, ANDA, DMF, and IND
- Prepare and submit INDs, NDAs, ANDAs, DMFs, and ANADA annual reports, amendments, and supplements in eCTD compliant format
- Provide regulatory support for post-marketing commercial activities, including preparing and reviewing supplements (PASs, CBE-30, and CBEs) for FDA submission
- Evaluate prototype formulations for future filings based on IID database, RLD labeling, RLD patent(s), and exclusivities
- Prepare Controlled Correspondences for FDA submission based on information provided by R&D department
- Write SOPs and maintain database
- Three to five years of regulatory experience in the pharmaceutical industry
- Bachelor's or Master's Degree in a scientific discipline or equivalent
- Strong written and verbal communication skills
- Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements
- Ability to work effectively in a highly charged, fluid environment
- Competitive base compensation pay range of $98,000 to $119,500
- Annual Performance Bonus Plan
- Employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program
- Paid time off benefits, including vacation time and sick time
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Air Compliance Specialist
1 month ago
Hawthorne, California, United States SST Direct Full timeJob Title: Air Compliance SpecialistSST Direct is seeking an experienced Air Compliance Specialist to join our team in Hawthorne, NV. This is a direct hire opportunity that offers a competitive salary and comprehensive benefits package.Job Summary:The Air Compliance Specialist will be responsible for managing and maintaining two Nevada air quality permits,...
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Senior Vehicle Ergonomics Specialist
2 weeks ago
Hawthorne, California, United States Tesla Full timeJob Title: Senior Vehicle Ergonomics SpecialistTesla is seeking a highly skilled Senior Vehicle Ergonomics Specialist to join our team. As a key member of our vehicle ergonomics team, you will be responsible for designing and developing innovative vehicle interior solutions that meet the needs of our customers.Key Responsibilities:Develop and implement...
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Air Compliance Specialist
2 weeks ago
Hawthorne, California, United States SST Direct Full timeJob Title: Air Compliance SpecialistAt SST Direct, we are seeking a highly skilled Air Compliance Specialist to join our team. This role is responsible for managing and maintaining air quality permits, ensuring compliance with regulations, and coordinating with personnel and regulators.Key Responsibilities:Manage and maintain air quality permits to ensure...
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Air Compliance Specialist
1 week ago
Hawthorne, California, United States SST Direct Full timeJob Summary: We are seeking an experienced Air Compliance Specialist to join our team at SST Direct in Hawthorne, NV. This role offers a competitive salary and comprehensive benefits package.Responsibilities:Manage and maintain Nevada air quality permits to ensure compliance with regulations.Coordinate with personnel and regulators on air compliance...
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Document Control Specialist
1 week ago
Hawthorne, California, United States OSI Systems Full timeAt OSI Systems, we are seeking a highly organized and detail-oriented Document Control Specialist to join our team. This role is responsible for ensuring the control and protection of quality and engineering related documents using a variety of information systems.The ideal candidate will have 1+ years of experience in document control within a manufacturing...
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Retail Sales Specialist, LATAM
2 weeks ago
Hawthorne, California, United States SpaceX Full timeAt SpaceX, we're pushing the boundaries of what's possible with our revolutionary satellite constellation, Starlink. As a Retail Sales Specialist, you'll play a critical role in driving growth and revenue for our retail partnerships in Latin America and beyond.Your primary responsibility will be to identify, develop, and execute retail partnership...
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Retail Channel Specialist, LATAM
4 weeks ago
Hawthorne, California, United States SpaceX Full timeJob Title: Retail Channel Specialist, LATAMJoin SpaceX, a pioneering company in the field of space technology, as a Retail Channel Specialist, LATAM. In this role, you will be responsible for identifying, developing, and executing retail partnership opportunities in domestic and international markets.Responsibilities:Support Starlink's growth in identifying,...
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Procurement Specialist
6 days ago
Hawthorne, California, United States Astrolab Full timeProcurement SpecialistAstrolab is seeking a highly skilled Procurement Specialist to join our team. As a Procurement Specialist, you will be responsible for sourcing, negotiating, and purchasing materials, components, and services needed to support our engineering and operations teams.Key Responsibilities:Develop base supporting critical commodities for all...
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Hawthorne, California, United States SpaceX Full timeJob SummarySpaceX is seeking a highly skilled and experienced Senior Environmental Health and Safety Specialist to join our team. As a key member of our Environmental Health and Safety department, you will be responsible for ensuring compliance with all applicable regulations and guidelines established by OSHA, NFPA, and NIOSH, as well as other regulatory...
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Electrical Engineer Supply Chain Specialist
2 weeks ago
Hawthorne, California, United States SpaceX Full timeElectrical Engineer Supply Chain Role at SpaceXAt SpaceX, we're pushing the boundaries of space exploration and development. As an Electrical Engineer Supply Chain Specialist, you'll play a critical role in ensuring the timely delivery of high-quality electrical components for our spacecraft and launch vehicles.Key Responsibilities:Collaborate with...
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Retail Sales Specialist, LATAM
2 weeks ago
Hawthorne, California, United States SpaceX Full timeJob SummaryJoin SpaceX as a Retail Sales Specialist, LATAM (Starlink) and play a critical role in driving the growth of our Starlink retail partnerships in Latin America. As a key member of our Starlink Retail Partnerships team, you will be responsible for identifying, developing, and capturing new retail partnership opportunities, as well as serving as the...
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Quality Assurance Specialist
2 weeks ago
Hawthorne, California, United States Space Exploration Technologies Corporation Full timeQuality Inspector, AvionicsSupports multiple avionics assembly and testing operations by providing in-process inspection and final verification of production hardware to drawing, process specifications, and work order requirements.Key Responsibilities:Verify production hardware against drawing, process specifications, and work order requirementsConduct...
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Environmental Health Specialist
1 week ago
Hawthorne, California, United States SpaceX Full timeAt SpaceX, we are committed to creating a safe and healthy work environment for our employees. We are seeking an Environmental Health Specialist to join our team and contribute to our mission of making humanity a multi-planetary species.The successful candidate will be responsible for developing and maintaining compliance with all applicable regulations and...
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Environmental Compliance Specialist
1 week ago
Hawthorne, California, United States SST Direct Full timeJob SummaryWe are seeking an experienced Environmental Compliance Lead to join our team at SST Direct in Hawthorne, NV.This role offers a competitive salary range of $95,000 - $110,000 per year, along with a comprehensive benefits package including PTO, Medical, Dental, and 401k.The successful candidate will be responsible for managing and maintaining...
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Reliability Specialist
4 weeks ago
Hawthorne, California, United States Space Exploration Technologies Corporation Full timeMaintenance & Reliability EngineerThe Maintenance & Reliability Engineer plays a critical role in ensuring the smooth operation of production equipment in Falcon, Dragon, and Starshield programs at our Hawthorne facility.Key Responsibilities:Provide engineering support for planned and unplanned repairs, modifications, and upgrades of production...
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Environmental Health Specialist
1 month ago
Hawthorne, California, United States SpaceX Full timeJob Title: Environmental Health & Safety EngineerAt SpaceX, we are seeking an experienced Environmental Health & Safety Engineer to join our team. As a key member of our safety and environmental team, you will be responsible for ensuring compliance with all applicable regulations and guidelines established by OSHA, NFPA, and NIOSH, as well as other...
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Compliance Specialist
5 days ago
Hawthorne, California, United States SpaceX Full timeAt SpaceX, we are committed to creating a safe and compliant work environment. As a Compliance Technician, you will play a critical role in ensuring our production facility meets all regulatory requirements.Key Responsibilities:Develop and maintain confined space entry permits and ensure compliance with OSHA regulations.Monitor confined spaces and maintain...
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Facility Maintenance Specialist
2 months ago
Hawthorne, California, United States ABM Industries Full timeJob Overview The Facility Maintenance Specialist is responsible for the cleanliness and maintenance of designated areas. Compensation: $17.25 per hourThe compensation mentioned is the hourly range or the hourly rate for this role. The specific offer will depend on the applicant's experience, skills, abilities, geographic location, and alignment with market...
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Facilities Maintenance Specialist
2 months ago
Hawthorne, California, United States ABM Industries Full timeAbout the RoleWe are seeking a skilled Cleaner to join our team at ABM Industries. As a key member of our facilities maintenance team, you will be responsible for ensuring the cleanliness and upkeep of our assigned areas.ResponsibilitiesClean and maintain buildings and facilities to the highest standardsFollow established procedures for the use of chemical...
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Culinary Specialist
2 weeks ago
Hawthorne, California, United States Van Dyk Health Care Full timeJob Title: Cook - Assisted LivingJob SummaryVan Dyk Health Care is seeking a skilled Cook to join our team at our Assisted Living facility. As a Cook, you will be responsible for preparing and serving delicious meals to our residents, ensuring a high level of quality and presentation.ResponsibilitiesDevelop and implement menus that cater to the dietary needs...