Top 43 Cmc project manager Jobs in Remote

Sr. Manager, Regulatory Affairs
Vaxcyte —Remote
- $183,000 - $194,000 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Computer skills
Senior Global Program Manager
Viatris —Remote
- $95,000 - $193,000 a year
- Full-time
- Remote
- 7 years
- Writing skills
- English
Manager, Regulatory Affairs CMC
Iovance Biotherapeutics —Remote
- $140,000 - $160,000 a year
- Remote
- Microsoft Excel
- Bachelor of Science
- 8 years
Quick Apply
Senior Manager, Reference Standards & Reagents
Vera Therapeutics, Inc. —Remote
- $125,000 - $185,000 a year
- Remote
- Bachelor of Science
- 3 years
- Bachelor's degree
- Paid holidays
- Health insurance
Senior Manager, CMC Global Regulatory Affairs
Otsuka —Remote
- $150,034 - $224,250 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
- AD&D insurance
- Paid holidays
12d
Senior Manager, Radiochemist CMC
Blue Earth Diagnostics —Remote
- $130,000 - $145,000 a year
- Full-time
- Bachelor's degree
- Continuous improvement
- Travel
- Paid holidays
- Health insurance
Associate Director, Regulatory Affairs, CMC
GE HEALTHCARE —Remote
- $132,000 - $198,000 a year
- Pass drug screening
- English
- 3 years
- Health insurance
- Dental insurance
Director / Senior Director FSP Operational Delivery Lead - Remote based in the US
Thermo Fisher Scientific —North Carolina
- Full-time
- Remote
- Sales
- Analysis skills
- Bachelor's degree
4d
Senior Manager, Biologics Analytical Development (Bioassay)
Otsuka —Remote
- $150,034 - $224,250 a year
- Full-time
- 8 years
- Continuous improvement
- Doctor of Philosophy
- AD&D insurance
- Paid holidays
2d
Senior Program Manager (mRNA LNP, Drug Product CMC/Development)
Aldevron —Fargo, ND
- $150,000 - $170,000 a year
- Full-time
- Remote
- Bachelor of Science
- Analysis skills
- Continuous improvement
- Health insurance
- Dental insurance
10d
Senior Manager, Clinical Supply Chain
BeiGene —Remote
- $131,800 - $176,800 a year
- Full-time
- Master's degree
- Bachelor's degree
- Business Administration
- Health savings account
- Employee stock purchase plan
5d
MSAT Technical Lead – Drug Substance (Sr Manager)
Sobi —Morrisville, NC
- $140,000 - $165,000 a year
- Full-time
- Remote
- 3 years
- Team management
- Travel
- Health insurance
- Dental insurance
Quick Apply
Manager, Commercial Supply Chain
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $165,044 a year
- Remote
- 5 years
- Bachelor of Science
- Engineering
- Health insurance
11d
Revenue Integrity Educator II - Revenue Cycle
UT Southwestern —Dallas, TX
- 8 hour shift
- Remote
- 5 years
- Research
- Mid-level
- Paid parental leave
- Paid holidays
Talent Acquisition Specialist (Remote)
Commercial Metals Company —San Antonio, TX
- Remote
- Spanish
- Microsoft Excel
- Research
- Employee stock purchase plan
- Disability insurance
Revenue Integrity Educator III
UT Southwestern —Dallas, TX
- Full-time
- Remote
- 6 years
- RN License
- Internal Medicine
- Paid parental leave
- Paid holidays
Senior Director of Analytical Development
Syncromune —Remote
- $250,000 - $280,000 a year
- Full-time
- 11+ years
- English
- Master's degree
- Work from home
Quick Apply
9d
Manager, GMP Quality Assurance, Clinical, QA
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $165,044 a year
- Remote
- 6 years
- Bachelor's degree
- Travel
- Health insurance
Manager/Senior Manager, GMP Quality Assurance - Clinical, QA
Agios Pharmaceuticals —Cambridge, MA
- $110,029 - $196,553 a year
- Remote
- Bachelor's degree
- Travel
- Senior level
- Health insurance
Senior Manager, Investigational Supply Operations
AVEO Oncology —Boston, MA
- Remote
- Microsoft Excel
- Bachelor's degree
- Senior level
Quick Apply

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Sr. Manager, Regulatory Affairs

Vaxcyte -
Remote

Apply Now

Job Details

$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 32S and 32P.
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.

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.

Apply Now

Refine Your Search

cmc project manager jobs in remote

Sr. Manager, Regulatory Affairs

Senior Global Program Manager

Manager, Regulatory Affairs CMC

Senior Manager, Reference Standards & Reagents

Senior Manager, CMC Global Regulatory Affairs

Senior Manager, Radiochemist CMC

Associate Director, Regulatory Affairs, CMC

Director / Senior Director FSP Operational Delivery Lead - Remote based in the US

Senior Manager, Biologics Analytical Development (Bioassay)

Senior Program Manager (mRNA LNP, Drug Product CMC/Development)

Senior Manager, Clinical Supply Chain

MSAT Technical Lead – Drug Substance (Sr Manager)

Manager, Commercial Supply Chain

Revenue Integrity Educator II - Revenue Cycle

Talent Acquisition Specialist (Remote)

Revenue Integrity Educator III

Senior Director of Analytical Development

Manager, GMP Quality Assurance, Clinical, QA

Manager/Senior Manager, GMP Quality Assurance - Clinical, QA

Senior Manager, Investigational Supply Operations

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Join our Mission to Protect Humankind!

Summary:

Essential Functions:

Requirements:

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