Job offers: regulatory affairs specialist clinical indiana

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QC/QA Manager

The Judge Group :: South Bend, Indiana :: over 30 days ago

... Manufacturing Company is looking for: POSITION: QC/QA Manager LOCATION: South Bend Indiana SALARY: $95-105K + 15% Bonus DEGREE: Preferred EXPERIENCE: 4+ Years Manufacturing ... in all areas of food safety, quality and compliance. The manager is the liaison for regulatory personnel including onsite inspectors. The Manager provides management to all ...

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Manufacturing Manager

The Judge Group :: La Grange, North Carolina :: over 30 days ago

... problems to ensure minimum cost and prevent operation delay. Manage product yield material usage and material loss data. Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards and sanitation practices. Monitor and coordinate maintenance schedule as well as controlling costs of ...

Senior Regulatory Affairs Specialist - PMA FOCUSED

FPC of Valdosta :: Colorado :: 27 days ago

SENIOR REGULATORY AFFAIRS SPECIALIST - PMA FOCUSED Senior Regulatory Affairs Specialist - PMA FOCUSED DENVER, CO A leading medical device manufacturing company is seeking a full time Sr. ... to prepare regulatory documentation. KEYWORDS: PMA, RAC-US, EU, SUBMISSIONS, CLINICAL TRIALS, FDA, REGULATORY AFFAIRS, MEDICAL DEVICES, BIOLOGICS, ASEAN, APEC, ...

Corporate Regulatory Affairs Specialist

Alliance Scientific Solutions :: Massillon, Ohio :: 5 days ago

Alliance Scientific Solutions is currently recruiting for a REGULATORY AFFAIRS SPECIALIST FOR A GROWING FOOD MANUFACTURING COMPANY LOCATED NEAR CANTON, OH. THIS IS A HIGHLY VISIBLE POSITION WITH GROWTH OPPORTUNITY! POSITION OFFERS A STRONG BASE SALARY WITH BONUS POTENTIAL. ROBUST BENEFITS PACKAGE WITH COMPANY PERKS AND WELLNESS PROGRAMS. Reporting ...

Regulatory Affairs Associate (439031)

Advanced Clinical :: San Rafael, California :: over 30 days ago

Job Description: OVERVIEW:The Associate, Regulatory Affairs will be assisting the regulatory team in supporting clinical and/or nonclinical studies. RESPONSIBILITIES:Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of 0product development, including the ...

Sr. Mgr./Associate Director - Regulatory Affairs

Cameron Craig :: New Jersey :: over 30 days ago

... Company in the Central NJ area, is looking for a Sr. Mgr./Associate Director - Regulatory Affairs. The Sr. Mgr./Associate Director Regulatory Affairswill oversee a variety of ... LINE WITH THE PROJECT TEAMS GOALS. * WILL WORK ON CROSS-FUNCTIONAL PROJECT TEAMS, CLINICAL AND COMMERCIAL TEAMS, AND PROVIDE STRATEGIC REGULATORY LEADERSHIP. The qualified ...

Associate Director of Regulatory Affairs Strategy

Global Personnel Search Inc :: North Chicago, Illinois :: over 30 days ago

_ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS STRATEGY - GLOBAL / ONCOLOGY_ NORTH CHICAGO,ILLINOIS _POSITION SUMMARY:_ Accountable for the production of submission documents using electronic document management systems. Author, review, and submit new applications, supplements, reports and amendments, along with responses to Regulatory Agencies in the ...

Clinical / Regulatory Data Specialist (6912421)

BioPoint :: Bridgewater, New Jersey :: yesterday

BioPoint is seeking to hire a Clinical / Regulatory Data Specialist for a position in Bridgewater, NJ. The NDA/BLA Annual Report (AR) Clinical / Regulatory Project Data Specialist is responsible for ... pharma/biotech industry experience in clinical research or medical affairs. 2. Track record of successfully managing multiple complex projects ...

Sr. Regulatory Affairs Associate - CMC

Global Personnel Search Inc :: Columbus, Ohio :: 27 days ago

_SENIOR REGULATORY AFFAIRS ASSOCIATE CMC_ Columbus, OH _POSITION SUMMARY:_ This position, reporting to the Regulatory Affairs CMC Manager, supports the activities of the Regulatory Affairs department with emphasis on CMC submission elements. _POSITION RESPONSIBILITIES:_ * The Senior Regulatory Affairs Associate will prepare CMC elements for ...

Regulatory Affairs Specialist

Piper Companies :: Durham, North Carolina :: over 30 days ago

Job Description: Regulatory Affairs Specialist Piper Clinical Solutions is actively seeking an entry- to mid-level Regulatory Affairs Specialist to work with an international medical device company in the Raleigh-Durham (RTP) area. The Regulatory Affairs Specialist will be working on a team that supports international submissions, and will be ...

Sr. Manager, Regulatory Affairs (Clinical / Nonclinical)

GTS :: Culver City, California :: over 30 days ago

... 25+) at different stages of the approval process. Under the supervision of the Regulatory Affairs Sr. Director, you will have to opportunity to use your knowledge and experience ... and global) for biologic products in various phases of product lifecycle through clinical development, marketing approval and post-approval life-cycle. This includes ...

Regulatory Affairs - Manager / Sr. Manager

Cameron Craig :: Paramus, New Jersey :: over 30 days ago

Our client, a Major Global Pharmaceutical Company, is actively expanding their operations in the ***. They are currently looking for a Manager/Sr. Manager, Regulatory Affairs. The Manager/Sr. Manager will be responsible for submissions (IND/NDA/BLA) from "Cradle to Grave" - as well as the developmentand execution of global regulatory ...

Associate Director, Regulatory Affairs

GTS :: Westlake Village, California :: over 30 days ago

As the Associate Director of Regulatory Affairs you will support all clinical and non-clinical regulatory affairs activities for the companys products and research as well as summarize regulatory intelligence, provide regulatory input for regulatory submissions, and manage the compilation and review of all submissions for completeness and quality. ...

Senior Manager / Associate Director, Regulatory Affairs (Global / Oncology)

Cameron Craig :: San Francisco, California :: 21 days ago

SENIOR MANAGER / ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (GLOBAL / ONCOLOGY) SAN FRANCISCO BAY AREA * Create content and timelines of regulatory submissions * Identify regulatory issues and provide solutions * Lead content and publishing of documents for original INDs & NDAs * Lead efforts to produce an IND each yea * Lead preparations for ...

Regulatory Affairs CMC Associate (439033)

Advanced Clinical :: San Rafael, California :: over 30 days ago

Job Description: OVERVIEW:Reporting to the Manager/Senior Manager, Regulatory Affairs, CMC, youll be responsible for: - Coordinating the planning, preparation and submission of global regulatory CMC-related ... Direct-Hire Opportunities with Client Companies Let Advanced Clinical help you find a career in the clinical research industry! We ...

Regulatory Affairs Associate (439033)

Advanced Clinical :: San Rafael, California :: over 30 days ago

Job Description: OVERVIEW: Reporting to the Manager/Senior Manager, Regulatory Affairs, Chemistry Manufacturing and Controls (CMC), youll be responsible for:Coordinating the planning, preparation and submission of ... Direct-Hire Opportunities with Client Companies Let Advanced Clinical help you find a career in the clinical research industry! We ...

Clinical Data Standards Expert

3D Search, Inc. :: New Jersey :: over 30 days ago

Job Description: Provide experienced standard and regulatory compliant insight to Clinical Development Plans (CDP), Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) across the Innovative and Approved ... Pharmacology, Data Management, Biostatistics, Regulatory Affairs, ) to produce compliant datasets for regulatory submission. ...

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