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CMC Regulatory Affairs Specialist - Remote

Pace Life Sciences Vienna Virginia United States
(No Timezone Provided)

OVERVIEWMake an impact. Build a career.At Pace, we're committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you'll hear the same thing repeated again and again: we work here ...

AD/Director Regulatory CMC - Remote

Real Staffing New York New York United States
(No Timezone Provided)

Job Title: Associate Director/Director, Regulatory Affairs CMC - RemoteThe Position: This organization is looking for a Regulatory CMC leader to apply experience and leadership to their Regulatory Affairs CMC team. You will be responsible for the overall management of a portfolio of biological produ...

CMC Regulatory Affairs Manager----Remote

Infotree Service Inc Boston Massachusetts United States
(No Timezone Provided)

Company DescriptionBio-TechJob DescriptionRemote OR may sit at any client site, manager works in EST but open to candidates in different time zonesTitle: Regulatory CMC ManagerJob Description: Assist in the development of module 3 templates that will enable population by automation tools, and enable...

Director - Regulatory CMC (Remote Position)

Kersey & Associates, Inc Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC. This position will be 100% Remote. This position is responsible for developing and implementing CMC regulatory strategies to facilitate the progress of R&D drug development a...

Director - Regulatory CMC (Remote Position)

Tandem Neal Associates Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC. This position will be 100% Remote. This position is responsible for developing and implementing CMC regulatory strategies to facilitate the progress of R&D drug development a...

Director - Regulatory CMC (Remote Position)

Hire Horizons Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC. This position will be 100% Remote. This position is responsible for developing and implementing CMC regulatory strategies to facilitate the progress of R&D drug development a...

Director - Regulatory CMC (Remote Position)

Apple & Associates Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC. This position will be 100% Remote. This position is responsible for developing and implementing CMC regulatory strategies to facilitate the progress of R&D drug development a...

Director - Regulatory CMC (Remote Position)

Cypress Search Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC. This position will be 100% Remote. This position is responsible for developing and implementing CMC regulatory strategies to facilitate the progress of R&D drug development a...

Director - Regulatory CMC (Remote Position)

Bellish & Associates Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC. This position will be 100% Remote. This position is responsible for developing and implementing CMC regulatory strategies to facilitate the progress of R&D drug development a...

Director - Regulatory CMC (Remote Position)

Easley Resource Group Boston Massachusetts United States
(No Timezone Provided)

Our client, a growing Pharma company focused in Oncology, is looking for a Director/Sr. Director, Regulatory Affairs, CMC.This position will be 100% Remote.The Director/Sr. Director, Regulatory Affairs, CMC will also serve as a regulatory specialist on select project teams. Responsibilities:&nb...

100% Remote "Chemistry, Manufacturing and Control" (CMC) Global Regulatory Submissions

Alpha Consulting Corp Germantown Maryland United States
(No Timezone Provided)

Description: Functions as a member of the Biopharmaceutical Development (BPD) Scientific Writing (SW) team and, independently with limited guidance, manages the preparation and review process of regulatory documents for the quality (CMC) modules for global submissions across early and late s...

Regulatory Affairs Manager, CMC (Open to remote)

Amgen Inc. Los Angeles California United States
(No Timezone Provided)

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives al...

Director, Regulatory Affairs CMC (Remote Position)

Global Blood Therapeutics South San Francisco California United States
(No Timezone Provided)

DIRECTOR, REGULATORY AFFAIRS CMC (Remote Position) Position Summary: The Director, Regulatory Affairs will provide leadership and regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the tre...

Director US Regulatory Global Strategic Labelling - Remote Opportunity

CareerBuilder Deerfield Illinois United States
(No Timezone Provided)

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only g...

Senior Regulatory Affairs Specialist (Remote Possible)

Boehringer Ingelheim Pharmaceuticals, Inc Fremont California United States
(No Timezone Provided)

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and ...

Senior Regulatory Affairs Specialist (Remote Possible)

Boehringer Ingelheim Fremont California United States
(No Timezone Provided)

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.Boehringer Ingelheim Fremont is the rapidly...

Remote Regulatory CMC Manager

The Fountain Group Atlanta Georgia United States
(No Timezone Provided)

This position is REMOTE, EST hours. Looking for CMC Experience (working knowledge of CTD Module 3 preferably; ability to assess that documents and responses received from SMEs are appropriate and complete to close gaps) This role is responsible for supporting the GRA Compliance department. Mos...

Remote Regulatory CMC Manager

The Fountain Group Atlanta Georgia United States
(No Timezone Provided)

This position is REMOTE, EST hours. Looking for CMC Experience (working knowledge of CTD Module 3 preferably; ability to assess that documents and responses received from SMEs are appropriate and complete to close gaps) This role is responsible for supporting the GRA Compliance department. Mos...

Senior Regulatory Affairs Specialist (Remote Possible)

Boehringer Ingelheim Fremont California United States
(No Timezone Provided)

Description: Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheim's Biologics Business Unit. We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug ...

Regulatory Affairs Manager, CMC (Open to remote)

Amgen Los Angeles California United States
(No Timezone Provided)

**HOW MIGHT YOU DEFY IMAGINATION?**You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becom...

CMC Regulatory Affairs Manager--Remote-must work in EST

Infotree Service Inc Thousand Oaks California United States
(No Timezone Provided)

Company DescriptionBio-TechJob Description* This candidate will be fully remote & must work in EST* This is an individual contributor - managing a processJob Details: The Regulatory Affairs Manager, CMC will lead registrations of client synthetics products and will be also the lead for life-cycle ma...

Regulatory CMC Senior Executive - UK Remote

Aerotek Middlesex Middlesex United Kingdom
(No Timezone Provided)

An Amazing opportunity to work with an Global Leading Pharmaceutical company!They are looking for Regulatory Affairs professionals with strong CMC experience to join their team as Senior Regulatory Affairs Executives, This is a role with multiple headcount due to a number of exciting projects being ...

Regulatory Affairs Manager, CMC (Open to remote)

Amgen Los Angeles California United States
(No Timezone Provided)

HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one ...

Senior/Principal Scientist, Biologics Analytical Development (REMOTE)

GQR Global Markets Columbus Ohio United States
(No Timezone Provided)

Position Summary: We are seeking a Senior/Principal Scientist, Analytical Development to join our Analytical team.Position can be fully REMOTE.Lead and support Analytical Development activities related to analytical method development, product characterization and comparability assessment for multip...

Principal Medical Writer - Remote

takeda Lexington Massachusetts United States
(No Timezone Provided)

Job Description Principal Medical Writer - remote Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Medical Writer in our Lexington, MA office. At Takeda, we are transforming the pharmaceutical industry t...

Director US Regulatory Global Strategic Labelling - Remote Opportunity

Lundbeck Deerfield Illinois United States
(No Timezone Provided)

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only g...

Remote Drug Development Head

Cameron Craig Group None Pennsylvania United States
(No Timezone Provided)

My client is expanding and seeks a Drug Development Leader to take on the following tasks: * Provide drug development expertise and leadership for the portfolio of drug discovery and development projects. * Develop detailed CMC and nonclinical development plans to optimize the path for candidates t...

Remote Nurse Recruiter

Clinical Management Consultants Madison Wisconsin United States
(No Timezone Provided)

Clinical Management Consultants is excited to offer a rewarding career opportunity for a Remote Nurse Recruiter in Madison, WI and surrounding areas. This is a fully remote position. In this challenging and fast paced role, the Remote Nurse Recruiter will direct recruiting strategies, develop market...

Remote Medical Writer

Beacon Hill Cambridge Massachusetts United States
(No Timezone Provided)

Job Summary Title: Medical Writer Position Summary: The contract medical writer in this role is responsible for the creation of English-language medical writing deliverables for our client's oncology and rare genetic disease programs, ensuring the high-quality, timely, and efficient developm...

Principal Medical Writer - Remote

Sanofi None null United States
(No Timezone Provided)

Position Overview: The Principal Medical Writer is a key member of the Medical Writing team, the Clinical Trial Team (CTT) and Project Team. This is a position for a senior medical writer who has an extensive experience with the preparation of clinical documents and regulatory dossiers and has d...

Documentation Specialist - III (Remote - Only 2 days a week onsite)

Ascent Services Group Madison New Jersey United States
(No Timezone Provided)

Job Description Documentation Specialist - III (Senior)Hybrid role Candidate must work onsite at least 2 days a week.12 months of contract Job description: Alexx is an Animal Health Global GxP Document Management System used to store Regulatory relevant documents across R This system is run within t...

Contractor, Analytical Chemistry (Remote)

Rain Therapeutics Newark California United States
(No Timezone Provided)

Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options. Our f...

Remote Sr. Medical Writer Consultant

Global Channel Management, Inc Irvine California United States
(No Timezone Provided)

Remote Sr. Medical Writer Consultant needs 5 years medical writing experience in clinical development function at a pharmaceutical company or CRO Remote Sr. Medical Writer Consultant requires: Strong written and verbal communication skills, including fluency in oral and written English, with the abi...

Technical Director, Devices & Combination Products - Remote

Endo International plc Dublin Dublin Ireland
(No Timezone Provided)

We're looking for a candidate to fill this position in an exciting company. Responsibilities% of TimeOverall DC P Development Strategy & Individual Program ExpertiseSupport design and development of the new devices in support of Endo's innovative pipeline, with a priority on speed-to-patient, produc...

Biotech & Pharma Writer (Contract - remote)

Brafton None Florida United States
(No Timezone Provided)

Description This is a remote contract opportunity and is open to candidates in any US state.JOB DESCRIPTIONA Brafton Biotech & Pharma Writer is dedicated to producing strong, creative and industry specific pieces that are incorporated into content marketing campaigns for health and pharma clients. C...

Biotech & Pharma Writer (Contract - remote)

Brafton Portland Oregon United States
(No Timezone Provided)

Description This is a remote contract opportunity and is open to candidates in any US state.JOB DESCRIPTIONA Brafton Biotech & Pharma Writer is dedicated to producing strong, creative and industry specific pieces that are incorporated into content marketing campaigns for health and pharma clients. C...

REMOTE Medical Writer

The Planet Group None null United States
(No Timezone Provided)

Opportunities Details: Client Name: Otsuka Job Title: Medical Writer (2 openings) Contract/Engagement Duration: through 12/31/2022 Employment Type Eligible: no restriction Location: Remote but EST preferred Bill Rate: $124hr Target Pay Rate: $125k or $75hr Start Date Target: ASAP Job d...

Senior Director US Regulatory Global Strategic Labeling - Remote opportunity

CareerBuilder Deerfield Illinois United States
(No Timezone Provided)

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only g...

Principal Medical Writer (Remote)

Flynn Life Sciences Group, Inc. Philadelphia Pennsylvania United States
(No Timezone Provided)

PRINCIPAL MEDICAL WRITER (REMOTE)The principal medical writer serves as subject matter expert on clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. The principal medical writer may also provide guidance on document strategy for more complex...

CMC Project Manager (Remote)

Spectraforce Technologies Inc Atlanta Georgia United States
(No Timezone Provided)

Job Title: CMC Project Manager (remote) Location: Location: Gaithersburg or Remote EST time zone preferred. Duration:12 Months Job Description: The CMC Project Manager (PM) works collaboratively with CMC Team Leaders and CMC scientists to ensure project goals and milestones are ...

CMC Project Manager (Remote)

Spectraforce Technologies Inc Atlanta Georgia United States
(No Timezone Provided)

Job Title: CMC Project Manager (remote) Location: Location: Gaithersburg or Remote EST time zone preferred. Duration:12 Months Job Description: The CMC Project Manager (PM) works collaboratively with CMC Team Leaders and CMC scientists to ensure project goals and milestones are a...

Director US Regulatory Global Strategic Labelling - Remote Opportunity

The Judge Group Deerfield Illinois United States
(No Timezone Provided)

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only g...

Director, Pharmaceutical Manufacturing (Commercial Manufacturing SME) - ONSITE OR REMOTE

Gilead Sciences, Inc. San Mateo California United States
(No Timezone Provided)

Director, Pharmaceutical Manufacturing (Commercial Manufacturing SME) - ONSITE OR REMOTESpecific ResponsibilitiesGilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring...

Associate Manager, Medical Writing (Remote, USA) Transcatheter Heart Valve (THV)

Edwards Lifesciences Nashville Tennessee United States
(No Timezone Provided)

The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.We have an outstanding, rewarding opportunit...

Associate Manager, Medical Writing (Remote, USA) Transcatheter Heart Valve (THV)

Edwards Lifesciences Philadelphia Pennsylvania United States
(No Timezone Provided)

The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.We have an outstanding, rewarding opportunit...

100% Remote-GISTechnical Writer

Beacon Hill Sanderson Texas United States
(No Timezone Provided)

Note: This is a 100% Remote position. Selected Candidates will be working PST Hours.One of our clients in Los Angeles, California is looking for a Global Information Security (GIS) Technical Writer with the following skills and experience: This position will create technical documentation and cont...

Biotech & Pharma Writer (Contract - remote)

Brafton Chicago Illinois United States
(No Timezone Provided)

This is a remote contract opportunity and is open to candidates in any US state.JOB DESCRIPTIONA Brafton Biotech & Pharma Writer is dedicated to producing strong, creative and industry specific pieces that are incorporated into content marketing campaigns for health and pharma clients. Client experi...

Biotech & Pharma Writer (Contract - remote)

Brafton Portland Oregon United States
(No Timezone Provided)

This is a remote contract opportunity and is open to candidates in any US state.JOB DESCRIPTIONA Brafton Biotech & Pharma Writer is dedicated to producing strong, creative and industry specific pieces that are incorporated into content marketing campaigns for health and pharma clients. Client experi...

Biotech & Pharma Writer (Contract - remote)

Brafton Los Angeles California United States
(No Timezone Provided)

This is a remote contract opportunity and is open to candidates in any US state.JOB DESCRIPTIONA Brafton Biotech & Pharma Writer is dedicated to producing strong, creative and industry specific pieces that are incorporated into content marketing campaigns for health and pharma clients. Client experi...

Biotech & Pharma Writer (Contract - remote)

Brafton Atlanta Georgia United States
(No Timezone Provided)

This is a remote contract opportunity and is open to candidates in any US state.JOB DESCRIPTIONA Brafton Biotech & Pharma Writer is dedicated to producing strong, creative and industry specific pieces that are incorporated into content marketing campaigns for health and pharma clients. Client experi...