Top 26 analytical cmc Jobs in remote

Senior Labelling Strategist
High5 —Jersey City, NJ
- $50 - $58 an hour
- Temporary
- Remote
- Analysis skills
- Bachelor's degree
- Conflict management
CMC / Technical Operations Program Manager - Associate Director
Sobi —Raleigh, NC
- $153,000 - $211,000 a year
- Full-time
- Remote
- English
- 8 years
- Travel
- Health insurance
Quick Apply
Associate Director, Process Chemistry (Remote)
IMMUNEERING CORPORATION —San Diego, CA
- $170,000 - $210,000 a year
- Full-time
- Remote
- Bachelor of Science
- 8 years
- Bachelor's degree
Quick Apply
Coding Specialist III
UT Southwestern —Dallas, TX
- 8 hour shift
- Remote
- Anatomy knowledge
- Surgery
- High school diploma or GED
- Paid parental leave
- Paid holidays
Senior Manager/ Associate Director GMP Quality
Vor Bio —Boston, MA
- $160,000 - $200,000 a year
- Remote
- 8 years
- Analysis skills
- Senior level
- Health insurance
- 401(k)
Manager, Quality Control
Nuvalent, Inc. —Cambridge, MA
- $125,000 - $145,000 a year
- Remote
- Bachelor's degree
- Organizational skills
- Experience equivalent to degree accepted
- Health insurance
- Dental insurance
Quick Apply
6d
Manufacturing, Science and Technology Drug Product Lead
Sobi —Waltham, MA
- $125,000 - $165,000 a year
- Full-time
- Remote
- Writing skills
- English
- Travel
- Health insurance
Quick Apply
CMC & Manufacturing, Science and Technology Drug Substance Lead
Sobi —San Diego, CA
- $153,000 - $211,000 a year
- Full-time
- Remote
- Writing skills
- English
- Travel
- Health insurance
Quick Apply
Director, Commercial FP&A
Praxis Precision Medicines, Inc. —Boston, MA
- $200,000 - $220,000 a year
- Email
- Remote
- 11+ years
- Analysis skills
- Continuous improvement
Quick Apply
Head of Regulatory Affairs
Exegenesis Bio Inc —Lower Gwynedd, PA
- Remote
- Analysis skills
- Doctor of Philosophy
- Senior level
Quick Apply
MSAT Technical Lead – Drug Substance
Sobi —Morrisville, NC
- $153,000 - $211,000 a year
- Full-time
- Remote
- English
- Team management
- Travel
- Health insurance
- Dental insurance
Quick Apply
7d
Associate Director/Director, Technical Operations and Development - REMOTE East Coast Based
Beacon Therapeutics (USA) Inc —Cambridge, MA
- $158,000 - $220,000 a year
- Full-time
- Remote
- Manufacturing
- Senior level
- Health savings account
- Disability insurance
Quick Apply
8d
Associate Director/Director for Regulatory Affairs
Padagis LLC —Minneapolis, MN
- Remote
- 7 years
- Writing skills
- Analysis skills
Quick Apply
Associate Regional Manager
ACROBIOSYSTEMS INC —Houston, TX
- $80,000 - $95,000 a year
- Full-time
- Remote
- Up to 50% travel
- Pass drug screening
- Mid-level
Quick Apply
6d
Associate Director, Clinical Supply Chain
TheRas Inc —South San Francisco, CA
- Full-time
- Remote
- 7 years
- Master's degree
- Bachelor's degree
Associate Director, Biologics Drug Substance
Servier —Boston, MA
- $150,000 - $211,000 a year
- Full-time
- Remote
- Bachelor of Science
- English
- Bachelor's degree
- Disability insurance
- Health insurance
2d

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analytical cmc jobs near remote

Senior Labelling Strategist

High5 -
Jersey City, NJ

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Job Details

Temporary | Contract
$50 - $58 an hour

Qualifications

Project team coordination
Presentations for conferences or internal meetings
Drug regulation
Analysis skills
Bachelor's degree
Compliance training programs
Team training
Conflict management
Organizational skills
Leading team collaboration initiatives
Regulatory submission editing and review
Senior level
Cross-functional team management
Process management
Leadership
Standard operating procedures (SOPs)
Communication skills
Negotiation
Cross-functional communication

Full Job Description

Job Title : Senior Labelling Strategist – Labelling (Remote)

Pay Rate: $50/hr - $58/hr

Duration : 39 W, 1 D

With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it! We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people.

Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.

Welcome to the relentless pursuit of better.

Inviting applications for the role of Senior Labelling Strategist – Labelling

In this role, you will be expected to work to deadlines in a fairly high-pressure business environment while being a good great teammate.

Responsibilities

Create, prepare, and revise CCDS, US and EU labeling for mature and life cycle products assigned to obtain company and/or agency approval.
Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company.
Strong knowledge and experience of Rx to OTC switch requirements.
Provides oversight for team and provides strategic guidance on complex labeling projects.
Must be able to work with all levels of associates and direct management within the Company (domestic/international) and demonstrate good communication, interpersonal and organizational skills.
Anticipates any hurdles in implementation and acts to minimize them.
Demonstrated knowledge and understanding of regulatory requirements for the CCDS, US and EU and local labeling implementation and the dynamics of Labeling Team purpose and objectives.
Knowledge of the principles and concepts of Labeling, including generics, authorized generics, private labels, device/combination products
Ability to read and interpret HA regulations and guidance, and underlying SOPs
Proven ability to lead regulatory strategy into labeling strategy.
Strong ability to lead meetings and propose labeling strategy, working well in cross-functional teams, and able to negotiate, resolve conflict and build consensus.
Lead a multidisciplinary labeling working group and provide labeling strategy proposal (Global Regulatory Affairs, Global Pharmacovigilance, Global Medical Affairs, Legal, Communication, preclinical and CMC…)
Proficient in presenting to senior management when required.
Highly detail oriented, strong analytical and organized skills, project management skills, self-starter, leadership skills, critical thinking required, strong ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
Must be able to construct a Company Response (MAH response) for health authority questions related to labeling.
Be an active member of Response Teams within procedures such as European Arbitration/referrals, or work-sharing, PRAC questions (signal detection…)
Extensive knowledge of EU regulations; be up to date with EU guidance’s/regulations and inform management and team of changes.
Provide periodic training to the labeling team on EU regulations.

Qualifications we seek in you!

Bachelor’s degree, in scientific discipline, or relevant/equivalent with relevant years of experience in Regulatory Affairs Labeling or equivalent in highly regulated environment.

Apply Now

Refine Your Search

analytical cmc jobs in remote

Senior Labelling Strategist

CMC / Technical Operations Program Manager - Associate Director

Associate Director, Process Chemistry (Remote)

Coding Specialist III

Senior Manager/ Associate Director GMP Quality

Manager, Quality Control

Manufacturing, Science and Technology Drug Product Lead

CMC & Manufacturing, Science and Technology Drug Substance Lead

Director, Commercial FP&A

Head of Regulatory Affairs

MSAT Technical Lead – Drug Substance

Associate Director/Director, Technical Operations and Development - REMOTE East Coast Based

Associate Director/Director for Regulatory Affairs

Associate Regional Manager

Associate Director, Clinical Supply Chain

Associate Director, Biologics Drug Substance

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