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148 regulatory affairs project manager jobs in Fremont, CA

Manager/Senior Manager, CMC Regulatory Affairs

Pharmacyclics, Inc. Sunnyvale, CA

• Reviews CMC documentation to ensures they meet regulatory requirements. • Represents RA CMC at project team meetings and coordinates regulatory… Pharmacyclics, Inc.

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Manager, Regulatory Affairs

Cameron Craig Group 2 Reviews San Francisco, CA

• Contribute to regulatory strategies and present regulatory strategies at meetings • Manage regulatory timelines and plans to meet company goals… Cameron Craig Group

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Director, Regulatory Affairs

Nektar Therapeutics 31 Reviews San Francisco, CA

Responsible for oversight of all regulatory activities of regulatory team. Develops strategies for earliest possible approvals of drug applications… Beyond.com

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Senior Regulatory Affairs Manager, Advertising and Promotion

Actelion Pharmaceuticals 10 Reviews South San Francisco, CA

• Provide direction and supervision to assure quality and timely submission (including electronic submission) of advertising and promotion materials… TheJobNetwork

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Medical Director - Lymphoma

Pharthenogene San Francisco, CA

*** Post marketing clinical trials, interpretation of trial results and product life cycle management. *** Leadership of medical affairs teams… Jobvertise

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Associate Director, Regulatory Affairs

Impax Laboratories, Inc. 44 Reviews Hayward, CA

Coordinate responses on FDA guidances and other Agency proposals as it impacts business and lead preparation of submissions to the docket and/or… Ivy Exec

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Regulatory Affairs Manager

Immune Design South San Francisco, CA

Responsible to ensure all Regulatory Affairs (RA) deliverables associated with each project or other assignment are completed within defined… VentureLoop

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Senior Manager, Regulatory Affairs

Pharmacyclics, Inc. 57 Reviews Sunnyvale, CA

• Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs… Pharmacyclics, Inc.

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Senior Director/Executive Director, Regulatory Affairs

Jazz Pharmaceuticals 16 Reviews Palo Alto, CA

Provide senior-level expertise and leadership Provide an influential presence for Pharmaceuticals in the regulatory risk management field Represent… Ivy Exec

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Head of Regulatory Affairs

MyoKardia, Inc. South San Francisco, CA

• Establish and implement regulatory strategy across all development programs for the US, EU and other major markets • Contribute to detailed… MyoKardia, Inc.

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Manager, CMC Regulatory Affairs

Phil Ellis Associates, Inc. San Francisco, CA

-Plan, coordinate, and prepare regulatory documents such as original INDs, NDAs, and ANDAs, amendments and supplements as well as routine updates… Phil Ellis Associates, Inc.

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Director, International Clinical/Regulatory Affairs

Cepheid - US 40 Reviews Sunnyvale, CA

• Provides oversight, supervision, and mentorship to staff (clinical research assistant/clinical research associate). • Oversee the direction… Beyond.com

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Director, CMC Regulatory Affairs

Pharmacyclics, Inc. Sunnyvale, CA

• Develops and implents the regulatory CMC project plan from IND to NDA. • Develops CMC regulatory strategy for post approval submissions for… Pharmacyclics, Inc.

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Senior/Executive Medical Director

Pharmacyclics, Inc. Sunnyvale, CA

/Purpose: The Senior / Executive Medical Director will function as a scientific and medical resource for the Medical Affairs (MA) department at… Pharmacyclics, Inc.

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