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 ...

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 :: 2 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 ...

Regulatory Affairs Project Manager

Cameron Craig :: Fort Lauderdale, Florida :: over 30 days ago

Established, growing pharmaceutical manufacturer is seeking a Regulatory Affairs Project Manager for their Fort Lauderdale area location. THE REGULATORY AFFAIRS PROJECT MANAGER POSITION IS OPEN DUE TO GROWTH AND RELOCATION ASSISTANCE TO SUNNY SOUTH FLORIDA IS AVAILABLE. The Regulatory Affairs Project Manager will be responsible for US Regulatory ...

Associate Director of Regulatory Affairs Strategy

Global Personnel Search Inc :: North Chicago, Illinois :: 2 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 ...

Associate Director Regulatory Affairs, CMC Northeast

Cameron Craig :: New Jersey :: 11 days ago

ASSOCIATE DIRECTOR REGULATORY AFFAIRS, CMC NORTHEAST * Liaison between company and regulatory agencies for submissions and CMC issues * Develop submission strategies leading to approvals of applications. * Prepare, review, and create submissions and CMC sections for regulatory filings * Manage relationships with business stakeholders with ...

Associate Director, Regulatory Affairs - Global /

Elite Executive Search :: 10 days ago

ASSOCIATE DIRECTOR, REGULATORY AFFAIRS - GLOBAL / ONCOLOGY - MIDWEST * Responsible to write and file electronic submissions, manage projects and project deadlines * Create and implement regulatory strategy for North America * Be part of project decisions and as the Associate Director make the appropriate recommendations for project improvement * ...

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 :: 17 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 ...

Sr. Director, Regulatory Affairs

GTS :: Hayward, California :: 19 days ago

... around the world! This is an exciting time for us and we are seeking a seasoned Regulatory Affairs professional to step into this executive level role! If you enjoy projects that ... diseases. - Experience with regulatory aspects of CMC, preclinical, and clinical product development Education: BS/BA in Life Sciences, Engineering, or other ...

Regulatory Affairs Intern

Noven Pharmaceuticals :: New York, New York :: 3 days ago

Regulatory Affairs Intern - (952) Job Title Regulatory Affairs Intern Location New York Office - New York, NY 10118 US (Primary) Category R & D/Product Development Employment Status Intern Exemption Type Non-Exempt Shift Type First Shift Job Description Position: Paid Summer Internship - Pharmaceutical Industry. Company: Noven Pharmaceuticals, ...

Associate Director, Regulatory Affairs

GTS :: Westlake Village, California :: 4 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. ...

Regulatory CMC Change Control Specialist (2511)

BioPoint :: Lexington, Massachusetts :: 2 days ago

BioPoint is seeking to hire a Regulatory CMC Change Control Specialist for a position in Lexington, MA. DESCRIPTION Global Regulatory Affairs Chemistry, Manufacturing and Controls (CMC) The incumbent will assist in the management of change controls for the CMC regulatory affairs group for all biological, plasma and/or small molecule products. This ...

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 ...

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