Top 32 Regulatory affairs manager Jobs in Cypress Ca

Manager I, Regulatory Affairs Operations
Tarsus Pharmaceuticals —Irvine, CA
- $97,500 - $136,500 a year
- Hybrid work
- Microsoft Excel
- 5 years
- Office
- Paid holidays
- Dental insurance
Regulatory Affairs Manager I
Alcon —Lake Forest, CA
- $130,900 - $169,400 a year
- Full-time
- English
- High school diploma or GED
- Doctor of Philosophy
- Health insurance
- Paid time off
Regulatory Affairs Manager
Katalyst Healthcares & Life Sciences —Irvine, CA
- Contract
- 5 years
- Master's degree
- Bachelor's degree
Quick Apply
Senior Manager, Regulatory Affairs Strategy
Alcon —Lake Forest, CA
- $167,450 - $216,700 a year
- Full-time
- Doctoral degree
- High school
- 11+ years
- Health insurance
- Paid time off
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
AbbVie —Irvine, CA
- $124,500 - $236,500 a year
- Full-time
- Hybrid work
- Doctor of Philosophy
- Team management
- Experience equivalent to degree accepted
- Paid holidays
- Health insurance
6d
Project Manager, Regulatory Affairs
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $130,000 - $140,000 a year
- Full-time
- Remote
- 5 years
- Project management
- Travel
Quick Apply
6d
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid
AbbVie —Irvine, CA
- $124,500 - $236,500 a year
- 8 hour shift
- Hybrid work
- Doctor of Philosophy
- Experience equivalent to degree accepted
- Senior level
- Paid holidays
- Health insurance
Regulatory Affairs Manager
Huisong Pharmaceuticals —Santa Ana, CA
- $38 - $48 an hour
- Part-time
- 5 years
- Office
- Analysis skills
Quick Apply
Business Affairs Manager
Meta —Los Angeles, CA
- $122,000 - $180,000 a year
- 6 years
- US work authorization
- Organizational skills
Senior Manager, Regulatory & Quality Affairs
Medit USA Inc —Newport Beach, CA
- Full-time
- 7 years
- Bachelor's degree
- Senior level
Quick Apply
Project Manager - Education Administrative Office
Providence —Anaheim, CA
- $41.81 - $64.91 an hour
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
- Paid parental leave
- Paid holidays
Senior Regulatory Affairs Associate
Alcon —Lake Forest, CA
- $102,850 - $133,100 a year
- Full-time
- 11+ years
- English
- Research
- Health insurance
- Paid time off
Senior Director, Rates & Regulatory Affairs
Liberty Utilities —Downey, CA
- 11+ years
- Bachelor's degree
- Travel
- Free parking
- Employee assistance program
Regulatory Permitting & Licensing Manager, US logistics facilities
TikTok —Los Angeles, CA
- $102,600 - $198,360 a year
- Research
- Mid-level
- Bachelor's degree
- Paid parental leave
- Paid holidays
Tribal NEPA Project Manager
Onterris —California
- $95,000 - $120,000 a year
- Full-time
- 5 years
- Mid-level
- Analysis skills
Senior Director, Global Regulatory Affairs
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $245,000 - $265,000 a year
- Full-time
- Office
- Math
- Bachelor's degree
Quick Apply
Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)
Hydrafacial —Long Beach, CA
- $107,500 - $125,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Organizational skills
- Health savings account
- AD&D insurance
Quick Apply
Aviation Regulatory Affairs Manager
Rainmaker Technology Corporation —El Segundo, CA
- $120,000 - $140,000 a year
- Full-time
- Military
- Office
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Global Head of Injectable Aesthetics Regulatory Strategy
Galderma —Orange County, CA
- $260,000 - $365,000 a year
- Full-time
- Office
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
13d
Senior Manager, FAA Regulatory Compliance Engineer
Virgin Galactic —Tustin, CA
- $122,364 - $186,636 a year
- Full-time
- 5 years
- Engineering
- Maintenance

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Manager I, Regulatory Affairs Operations

Tarsus Pharmaceuticals
Irvine, CA

Apply Now

Job Details

$97,500 - $136,500 a year

Benefits

Paid holidays
On-site gym
Dental insurance
Paid time off
Vision insurance

Qualifications

Document control experience within pharmaceutical industry
E-filing platforms
Software administration
Information management

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.

Apply Now

Refine Your Search

regulatory affairs manager jobs in cypress ca

Manager I, Regulatory Affairs Operations

Regulatory Affairs Manager I

Regulatory Affairs Manager

Senior Manager, Regulatory Affairs Strategy

Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)

Project Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Therapeutic Neurotoxins - Hybrid

Regulatory Affairs Manager

Business Affairs Manager

Senior Manager, Regulatory & Quality Affairs

Project Manager - Education Administrative Office

Senior Regulatory Affairs Associate

Senior Director, Rates & Regulatory Affairs

Regulatory Permitting & Licensing Manager, US logistics facilities

Tribal NEPA Project Manager

Senior Director, Global Regulatory Affairs

Sr. Regulatory Affairs Specialist, Medical Devices (Long Beach, CA)

Aviation Regulatory Affairs Manager

Global Head of Injectable Aesthetics Regulatory Strategy

Senior Manager, FAA Regulatory Compliance Engineer

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