Jobs in the United States

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Holiday Gift Guide Retail Sales Ambassador, Cherry Creek - Full Time
Macy's
Denver, CO
- Full-time
Self-starter, able to work independently and as part of a team; must have excellent time management skills
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CLIENT ENGAGEMENT MANAGER
Palco
Boston, MA · Worcester, MA
Must have excellent verbal and written communication skills · 4 years of program management or project management experience required
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Dental Assistant
Nuvia MSO, LLC Brand
Fullerton, CA
- $25 to $30 USD / hour
Robust Dental Leadership Structure: You get the support you need ranging from an onsite dental assistant lead, regional dental assistants leads, and a dental assistant operations manager…
Added 1 min ago
Senior Safety Specialist I
Bechtel Corporation
Clay, NY
The Sr. Safety Specialist helps develop and execute the safety component of an Environmental, Safety, and Health (EHS) program. This involves administrative and field tasks per established…
Added 1 min ago
NDT Equipment Repair & Calibration Manager
MFE Inspection Solutions
Pasadena, TX
We're looking for a hands-on technical leader to run that operation. You'll lead the technicians, do repair and calibration work yourself, and build the procedures and quality program the…
Added 1 min ago
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Client Engagement Consultant
TIAA
Dallas, TX · Charlotte, NC
- $77,000 to $110,000 USD / year
Engages clients primarily through two channels: assigned leads generated by internal lead-generation processes, and proactive outreach to retain clients identified as at risk of moving…
Added 1 min ago
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Sr Info Security Gov & Risk Specialist
TIAA
3965 Dallas Parkway Frisco, TX · Charlotte, NC · Iselin, NJ
- $89,100 to $125,000 USD / year
…Under limited supervision, this role also supports the overall program and process execution of the supplier risk management team and business information security office to drive…
Added 1 min ago
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Third-Party Wealth Consultant
TIAA
Dallas, TX · Charlotte, NC
- $28.37 to $39.71 USD / hour
…who work with TIAA institutional and individual clients in support of the distribution of TIAA products and services. The Third-Party Wealth Consultant role is primarily responsible for…
Added 1 min ago
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Relationship Manager I
TIAA
Atlanta, GA · Charlotte, NC
- $78,000 to $108,000 USD / year
Must have Series 6 or Series 7 and obtain Series 63 within 120 days from date of hire
Added 1 min ago
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Production Forester
Nuveen Services LLC
Gearhart, OR
- $75,000 to $105,000 USD / year
Support and participate fully in local SFI program.
Added 1 min ago
Culinary Lead (Sur La Table)
CSC Generation
Westlake, OH
With over 58 stores and the largest avocational cooking program in the US, Sur La Table offers an unsurpassed selection of exclusive and premium-quality goods for the kitchen and table –…
Added 2 mins ago
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Clinical Supervisor
Wellness Together
San Diego, CA
- $43.27 to $50.48 USD / hour
Status: Part-Time (3 days per week- 7:30 am- 4:00 pm)
Added 2 mins ago
Senior Workers’ Compensation Claims Adjuster
Clearbrook Group Services Inc.
United States
Must have good business acumen (i.e · Must have excellent communication skills and the ability to build lasting relationships
Added 2 mins ago
Marketing Operations Manager
Clearbrook Group Services Inc.
United States
Manage the operation of the departmental merchandise store and event equipment program, including vendor relationships, product offerings, ordering, inventory, fulfillment, shipping,…
Added 2 mins ago
Manufacturing Engineer, AWS Power Electronics
Amazon Data Services, Inc.
Seattle, WA · Cupertino, CA
…analysis, create runbooks, train technicians and operators, and support recurring certification programs to ensure consistent quality across all sites. You analyze failure data to identify…
Added 3 mins ago
Market Manager Tier II Store
CSI Cellular South, Inc
Grenada, MS
…customer satisfaction across your designated market. You will lead both retail and enterprise sales efforts while overseeing the day-to-day operations of your market. This leadership role…
Added 3 mins ago
Director, Events (REMOTE) (copy)
EnableComp
Remote, United States
…webinars as the primary channels. The role plans and runs the program mix across those channels, including the pre- and post-event nurture that surrounds them, and holds accountability for…
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Marietta, GA
- $16.5 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Marietta, GA
- $16.5 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Bremerton, WA
- $19.25 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Sammamish, WA
- $20.5 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Arlington, TX
- $16 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Overland Park, KS
- $17.25 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
Columbia, TN
- $14.75 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.
Added 3 mins ago
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Entry-level Lube Tech/Technician
VIOC
MONTGOMERY, AL
- $14.5 USD / hour
Employee Assistance Program (EAP): Quick, free, and confidential well-being support for all areas of life, including personal and work relationships, family, mental health, and legal issues.

Aspen Neuroscience

Sr. Manager, Regulatory Affairs

San Diego, CA, United States

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Job details

Experience: Minimum of 6-8 years of progressively responsible regulatory affairs experience within biotechnology, cell therapy, pharmaceuticals, medical device, or related industries
Posting language: English

Original job description

The Senior Manager, Regulatory Affairs is a senior individual contributor who supports regulatory strategy execution for assigned clinical-stage cell and gene therapy programs. Serving as a recognized regulatory subject matter expert, this role collaborates and evaluates complex and evolving requirements, establishes regulatory approaches, and communicates program decisions. This role collaborates closely with colleagues across regulatory operations, quality, CMC, nonclinical, and clinical functions to support high-quality, timely regulatory submissions. The position supports execution and may lead submissions and coordinate health authority interactions, driving alignment among internal and external stakeholders while maintaining compliance with applicable regulations. This position is a hybrid role, preferably with candidates near the San Diego area.

DUTIES AND RESPONSIBILITIES:

Support regulatory submissions and contribute to strategic planning for assigned programs.
Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
Develop, manage and track regulatory submission timelines.
Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
Review essential document packages and support site start-up activities from regulatory perspective.
Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
Contribute to the development and review of standard operating procedures to ensure regulatory compliance.
Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Promote a culture of quality and continuous improvement across the organization.
Support cross-functional initiatives and continuous improvement efforts.
Perform additional duties as assigned.
Up to 10% travel.

JOB SPECIFICATIONS:

Experience in preparing regulatory submissions (e.g., IND, DSUR, CTA, FDA meeting requests).
Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
Good project management skills; able to manage multiple projects simultaneously and meet deadlines.
High attention to detail, with excellent problem-solving and analytical thinking abilities.
Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (e.g., investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
Computer expertise, including Microsoft Office Suite proficiency (eg, Word, Excel, PowerPoint). Experience with regulatory information management system (Veeva RIM) is a plus.

EDUCATION AND EXPERIENCE:

Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related scientific discipline required; advanced degree preferred.
Minimum of 6-8 years of progressively responsible regulatory affairs experience within biotechnology, cell therapy, pharmaceuticals, medical device, or related industries
Broad understanding of international GXP regulations, guidelines, processes, publishing standards, and issues in drug/biologics development is strongly preferred.
Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat.

WORKING CONDITIONS

General Office Environment. This is an indoor position that requires sitting at a desk for extended periods of time and the ability to type and use a computer. The noise level in the work environment is usually quiet to moderate.

PHYSICAL DEMANDS

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

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Jobs in the United States