Top 31 Regulatory affairs manager Jobs in Sunnyvale, Ca

Sr. Manager, Regulatory Affairs
Vaxcyte —San Carlos, CA
- $183,000 - $194,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Computer skills
Manager, Regulatory Affairs
Noctrix Health —Pleasanton, CA
- $150,000 - $180,000 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Office
Quick Apply
9d
Manager, Regulatory Affairs, Regulatory PMO
Google —Mountain View, CA
- $211,000 - $293,000 a year
- Full-time
- Office
- Bachelor's degree
- Mentoring
5d
Manager, Regulatory Affairs CMC
Gilead Sciences —Foster City, CA
- $146,540 - $189,640 a year
- Full-time
- Bachelor's degree
- Continuous improvement
- Senior level
- Health insurance
- Dental insurance
Regulatory Affairs Manager – Heart Failure (on-site)
Abbott Laboratories —Pleasanton, CA
- $114,000 - $228,000 a year
- Full-time
- 6 years
- Supervising experience
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Sr Manager, Regulatory Affairs CMC, Combination Products and Device
Gilead Sciences —Foster City, CA
- $157,590 - $203,940 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
11d
Manager, Regulatory Response
Google —Mountain View, CA
- $211,000 - $293,000 a year
- Full-time
- Office
- Supervising experience
- Bachelor's degree
- Paid holidays
- Disability insurance
9d
Business Affairs Manager
Meta —Burlingame, CA
- $122,000 - $180,000 a year
- 6 years
- Office
- US work authorization
Safety Program Manager (Trust building), TikTok Platform Responsibility
TikTok —San Jose, CA
- $108,000 - $208,800 a year
- Office
- Fair chance
- Senior level
- Paid parental leave
- Paid holidays
Regulatory Affairs Associate (Principal) - Medical Devices
Apple —Cupertino, CA
- $178,400 - $297,200 a year
- Bachelor of Science
- Team management
- Experience equivalent to degree accepted
- Employee stock purchase plan
- Health insurance
Senior Manager, Commercial Regulatory Operations
Corcept Therapeutics —Redwood City, CA
- $194,000 - $227,000 a year
- Hybrid work
- 6 years
- Bachelor of Science
- Office
Quick Apply
Senior Program Manager, Regulatory Compliance
Google —Sunnyvale, CA
- $164,000 - $239,000 a year
- Full-time
- Office
- Bachelor's degree
- Fair chance
9d
Deputy Chief Compliance Officer
Western Digital —San Jose, CA
- $262,700 - $350,200 a year
- Full-time
- Hybrid work
- 11+ years
- Office
- Master's degree
- Health savings account
- AD&D insurance
Quick Apply
9d
Principal Regulatory Affairs Specialist – Vascular (on-site)
Abbott Laboratories —Santa Clara, CA
- $100,000 - $200,000 a year
- Full-time
- 6 years
- Bachelor's degree
- Product management
- Health insurance
- Tuition reimbursement
Senior Vice President, Chief Ethics & Compliance Office
Gilead Sciences —Foster City, CA
- Full-time
- HIPAA
- 11+ years
- Office
Senior Project Manager (Product Lifecycle Manager)
Abbott Laboratories —Pleasanton, CA
- $114,000 - $228,000 a year
- Full-time
- 7 years
- Management
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Director, International Regulatory Affairs #4809
GRAIL, Inc. —Sunnyvale, CA
- $169,000 - $242,000 a year
- Full-time
- HIPAA
- Master's degree
- Doctor of Philosophy
- Health insurance
- Dental insurance
9d
Sr. Project Manager, Clinical Affairs
Intuitive Surgical —Sunnyvale, CA
- $127,900 - $216,500 a year
- Day shift
- Surgery
- 5 years
- Presentation skills
Program Manager, Specialized Risk Assessment
Meta —Menlo Park, CA
- $153,000 - $209,000 a year
- 7 years
- Writing skills
- Bachelor's degree
11d
Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810
GRAIL, Inc. —Sunnyvale, CA
- $189,000 - $271,000 a year
- Full-time
- Hybrid work
- Master's degree
- Doctor of Philosophy
- Organizational skills
- Health insurance
- Dental insurance
9d

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Sr. Manager, Regulatory Affairs

Vaxcyte -
San Carlos, CA

Apply Now

Job Details

Full-time
$183,000 - $194,000 a year

Qualifications

Bachelor's degree
Computer skills
Achieving project delivery timelines

Full Job Description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations.

Essential Functions:

Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
Manage preparation of responses to queries from regulatory authorities.
Ensure conformance to commitments made with various regulatory agencies.
Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks.
Manage coordination, preparation, and timely submission of regulatory documents and filings.
Review and approve change controls related to proposed product/process changes and asses their impact against regulatory requirements.
Cultivate productive working relationships with the Regulatory team and other departments.
Coordinate responses to CMC-related queries from Health Authorities.

Requirements:

Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
Prior experience preparing/authoring CMC DS sections:
- BLA highly preferred.
- IND highly preferred.
- IMPD.
Prior development or manufacturing experience is a plus.
Experience with module 3.2S and 3.2P.
Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte’s achievement of business objectives.

Reports to: Executive Director, Regulatory CMC

Location: US - Remote

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):

Remote

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $183,000 - $194,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Relocation:

This role is not eligible for relocation assistance.

Equal Opportunity

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Recruitment Fraud Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.

Apply Now

Refine Your Search

regulatory affairs manager jobs in sunnyvale, ca

Sr. Manager, Regulatory Affairs

Manager, Regulatory Affairs

Manager, Regulatory Affairs, Regulatory PMO

Manager, Regulatory Affairs CMC

Regulatory Affairs Manager – Heart Failure (on-site)

Sr Manager, Regulatory Affairs CMC, Combination Products and Device

Manager, Regulatory Response

Business Affairs Manager

Safety Program Manager (Trust building), TikTok Platform Responsibility

Regulatory Affairs Associate (Principal) - Medical Devices

Senior Manager, Commercial Regulatory Operations

Senior Program Manager, Regulatory Compliance

Deputy Chief Compliance Officer

Principal Regulatory Affairs Specialist – Vascular (on-site)

Senior Vice President, Chief Ethics & Compliance Office

Senior Project Manager (Product Lifecycle Manager)

Director, International Regulatory Affairs #4809

Sr. Project Manager, Clinical Affairs

Program Manager, Specialized Risk Assessment

Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810

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Join our Mission to Protect Humankind!

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Requirements:

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