About the Role The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and re…
About the Role The Sr. Scientist, Analytical Development is responsible for leading analytical activities supporting clinical-stage drug substance and drug product development programs. This role provides phase-appropria…
Life Sciences Sales Account Manager - Southwest (Water Technologies)
Irvine, California, United States · On-site
$90k–$115k/yr
Senior
Company Description Veolia Group is a global leader in environmental services, operating across all five continents with nearly 218,000 employees. Specializing in water, energy, and waste management. Veolia Group designs…
Skills: Sales account management, Analytical instruments, Life sciences, Pharmaceutical industry, Total organic carbon
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standard…
Job DetailsJob Location: Irvine - Irvine, CA 92614Position Type: Per DiemSalary Range: $28.00 - $35.00 Hourly*Please note: this is a per diem position* Do you have a passion for helping people achieve their dreams of a g…
Behavioral Health Technician (Beachside Recovery) - Graveyard schedule
Irvine, California, United States · On-site
Entry level
Job description: Beachside Behavioral Health is URGENTLY seeking a Behavioral Health Technician for our Tustin/Santa Ana location. We are a detox residential facility looking to fill all shifts. This candidate must have …
Job DetailsJob Location: Irvine - Irvine, CA 92614Position Type: Per DiemSalary Range: $42.00 - $50.00 HourlyWho We Are Do you have a passion for helping people achieve their dreams of a growing family? An exciting oppor…
Skills: Registered Nurse, Pre-op Care, Post-op Recovery, IV Administration, Patient Monitoring
About Us Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, cli…
Skills: Manufacturing, Production, Hand-eye coordination, Attention to detail, Machinery operation
Description Now is the time to join PDS Health. You will have opportunities to learn new skills from our team of experienced professionals. If you're ready to take your career to the next level and gain valuable experien…
Skills: Leadership development, Coaching, Strategic planning, Public speaking, Talent development
Easterseals Southern California transforms lives every day. For over a century, Easterseals has championed inclusion and independence—delivering essential services like early childhood programs, autism services, employme…
Company Overview Healthpeak Properties is a fully integrated real estate investment trust (REIT) and an S&P 500 company. We specialize in owning, operating, and developing high-quality real estate focused on healthcare d…
Company Overview Healthpeak Properties is a fully integrated real estate investment trust (REIT) and an S&P 500 company. We specialize in owning, operating, and developing high-quality real estate focused on healthcare d…
Skills: Real estate law, Transaction management, Contract negotiation, Due diligence, Financing
Position Summary PT-Stretch Specialists are responsible for supporting all members in championing happier, and healthier lives by building and nurturing relationships. They will provide branded Assisted Stretch and Recov…
Description Now is the time to join PDS Health. You will have opportunities to learn new skills from our team of experienced professionals. If you're ready to take your career to the next level and gain valuable experien…
Skills: Search engine optimization, Answer engine optimization, Generative engine optimization, Technical SEO, Structured data
Patient Care Assistant I - Multiple openings Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illness…
Skills: Patient care, Clinical support, Nursing assistance, Communication, Teamwork
Company Overview Healthpeak Properties is a fully integrated real estate investment trust (REIT) and an S&P 500 company. We specialize in owning, operating, and developing high-quality real estate focused on healthcare d…
Hours: 40 hours per week; Monday through Friday - 7:00 AM to 3:30 PM Location: Onsite training required for first 180 days at 55 Technology Drive - Lowell, MA. Remote flexibility may offered at discretion of the manager …
Overview Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptional care to our patients. Our mission is to improv…
BCI seeks a dedicated and passionate Healthcare Security Officer to serve as an integral part of the security and care delivery team for a leading healthcare provider. Blackstone Consulting, Inc. (BCI) is a minority-owne…
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanc…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$98k–$137k/yr
Full-time
bachelor degree
Health insurance, Dental insurance, Vision insurance, Paid time off, Vacation, Holidays
Posted 24d ago
~40 hrs/week
Responsibilities
The manager will assist in managing the Electronic Document Management System and regulatory submission activities, including content planning and dossier lifecycle management. They will also support the regulatory affairs team with project management, process development, and coordination with external publishing vendors.
Requirements
Candidates must have a bachelor's degree in a science or health-related discipline and at least 5 years of experience in regulatory affairs operations. Proficiency in Veeva Vault RIM and a deep understanding of FDA, EMA, and ICH regulatory guidelines are required.
Full job description
About the Role
The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities.
Let’s talk about some of the key responsibilities of the role:
Create and Maintain Content Plans within Veeva Vault RIM, understanding of eCTD Hierarchy/Modules and content planning.
Assist with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, dossier lifecycle management. Maintain compliance to regulatory requirements for annual reporting, etc.
Support RA submissions team/s with project management activities, tasks and tracking.
Assist with coordination and communication of regulatory submissions with external Publishing vendors.
Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
Assist in Reg Ops team management and help to develop fully functional regulatory operations team, including processes and systems.
Excellent organization, written/verbal communication and attention to detail.
EDMS & Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems (proficiency in Veeva RIMS required). In addition, proficiency working with eCTD templates (e.g., eCTD StartingPoint® Templates, etc.). Preferred technology: Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox.
Project Management Technology: Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc.
Maintenance of individual training records and completion of all designated required training.
Factors for Success:
Bachelor’s degree in science or health-related discipline or equivalent experience.
Minimum of 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management, records management.
In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management.
Experience working with Veeva Regulatory Information Management System Vault is required; administrator experience/management of Veeva RIMS is a requirement.
Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to RA operational activities.
Demonstrated ability to contribute to a continuous learning and process improvement.
Strong analytical skills, good attention to detail.
Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Ability to work independently as needed with minimal supervision.
Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.
A Few Other Details Worth Mentioning:
The position will be based in our beautiful Irvine office, complete with an onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment; remote work may be considered.
We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
This position reports directly to our Director, Regulatory Affairs Operations.
Some travel may be required – up to 20%.
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $97,500 - $136,500 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.
#LI-Hybrid
#LI-Remote
Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Tarsus (NASDAQ:TARS) is a biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients, starting with eye care.
Offices: 15440 Laguna Canyon Rd, Irvine, California 92618, US
How many Healthcare jobs are open in Irvine, CA right now?
There are currently 1,118 open healthcare positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Irvine, CA?
Companies currently hiring include UCI Health, Edwards Lifesciences, City of Hope, Allergan, Hoag Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Irvine, CA?
Yes — 200 of the 1118 open healthcare positions offer remote or hybrid work (69 remote, 131 hybrid).
How do I apply for Healthcare jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.