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Manager, Regulatory Affairs Jobs

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Senior Manager, Regulatory Affairs

Relypsa

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a

4/12/2016  Redwood City, CA  Save This Job

Manager - Regulatory Affairs

FibroGen

Responsibilities: Review, provide comments on, and prepare documents for submission to FDA and international regulatory authorities including protocols, investigator brochures, nonclinical and CMC amendments, and other regulatory submissions. Lead teams on the timely preparation,

5/3/2016  San Francisco, CA  Save This Job

Senior Associate, Regulatory Affairs

Sagent Pharmaceuticals

Location: Schaumburg, Illinois, USA Senior Associate, Regulatory Affairs Reports To: Senior Manager, Regulatory Affairs Job Summary / Overview: Responsible for the support of Pre and Post approval regulatory affairs activities as directed by the Senior Manager which may

4/10/2016  Schaumburg, IL  Save This Job

Associate Director, Regulatory Affairs

Aprecia Pharmaceuticals

Job ID87 OverviewResponsible for independently developing regulatory strategy and filings (e.g. Annual Reports, Supplements, CBEs (Changes Being Effected), Protocols, etc.), providing critical review of CMC (Chemistry, Manufacturing, and Controls) and clinical submissions,

4/4/2016  Blue Ash, OH  Save This Job

Regulatory Affairs Manager (001121)

Sotera Wireless

Job Details Regulatory Affairs Manager (001121) Job Number:001121 Job Title:Regulatory Affairs Manager Number of Openings:1 Job Type (Employment Type):Direct Hire Country:United States State/Province:California City:San Diego Job Schedule:Full Time Level of Education:Bachelor's

4/24/2016  San Diego, CA  Save This Job

Regulatory Affairs Project Manager

Globus Medical

Regulatory Affairs Project Manager Location:Audubon, PA Job Code:RAPMCK0314 Description The Regulatory Affairs Project Manager assists in writing, submitting and gaining approval of 510(k) and IDE/PMA submissions to the Food and Drug administration (FDA) for class II and class

4/17/2016  Audubon, PA  Save This Job

MANAGER, FP&A: CLINICAL RESEARCH & DEVELOPMENT, REGULATORY AFFAIRS &

Cytokinetics

COMPLIANCE Department: Finance Job Location: South San Francisco Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle

4/5/2016  South San Francisco, CA  Save This Job

Regulatory Affairs Manager or Sr. Manager

MacroGenics

Description/Job Summary MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 200+ dedicated individuals is advancing a pipeline of product candidates to treat patients with

3/27/2016  Rockville, MD  Save This Job

Regulatory Affairs Manager (CMC)

Alder Biopharmaceuticals

Job Description: The responsibilities of this newly created position will focus on being the lead individual supporting the development and implementation of CMC regulatory strategies for Alder BioPharmaceuticals development programs. This includes responsibility for direct

4/20/2016  Bothell, WA  Save This Job

Manager, Regulatory Operations

OncoMed Pharmaceuticals

Description: Job Summary The Manager of Regulatory Operations will be responsible for the planning, scheduling and coordination of eCTD submissions in collaboration with internal team members/functional areas, partner companies and contract research organizations. He/she will

5/6/2016  Redwood City, CA  Save This Job

Clinical Supply Manager

Merrimack Pharmaceuticals

Product Supply Cambridge, MA, United States We are looking for a talented Clinical Supply Manager to join our team in Cambridge! Job Responsibilities: Work closely with Clinical Operations to monitor and track clinical trial enrollment plans and actual enrollment Collaborate

5/17/2016  Cambridge, MA  Save This Job

Clinical Trial Manager

Promedior

Job Description The Clinical Trial Manager in collaboration with the Clinical Project Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities?

4/23/2016  Boston, MA  Save This Job

Manager / Sr. Manager of Regulatory Operations

FibroGen

The Manager / Sr. Manager of Regulatory Operations is responsible for oversight and hands-on day-to-day support of Regulatory Operations. This role will actively participate in Paper and Electronic dossiers for submissions to Global Regulatory Health Authorities (i.e., FDA,

5/3/2016  San Francisco, CA  Save This Job

Director of Quality Assurance and Regulatory Affair

TeraRecon

Location:USA - CA Company Order Number:397 # of openings:1 Description About the Company TeraRecon is the largest independent, vendor neutral medical image viewing solution provider with a focus on advanced image processing innovation. TeraRecon iNtuition and iNteract+ solutions

4/20/2016  San Mateo, CA  Save This Job

International Regulatory Project Manager

Globus Medical

Location:Audubon, PA Job Code:IRPMLB0216 Description The International Project Manager writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with

4/17/2016  Audubon, PA  Save This Job

Zequanox Product Manager

Marrone Organic Innovations

Location: MBI Headquarters, Davis, CA Reports to: Vice President of Regulatory and Government Affairs Summary The Zequanox Product Manager will play a critical role in ensuring customer success and satisfaction and to accelerate the adoption of the Zequanox product. The chosen

5/17/2016  Davis, CA  Save This Job

International Regulatory Associate

Globus Medical

Location:Audubon, PA Job Code:IRALB0516 Description The International Regulatory Associate maintains CE Technical Files and registrations for international Regulatory agencies. This position entails working knowledge of products under review and of relevant regulations and

5/17/2016  Audubon, PA  Save This Job

MEDICAL AFFAIRS MANAGER

Zeltiq Aesthetics, Inc.

Location:Pleasanton, California DESCRIPTION Summary: Provide medical information and clinical support in post-market commercial use and continued learning of ZELTIQ products. Responsible for the operation of the Clinical Outcome Support group. To facilitate and maintain an

4/24/2016  Pleasanton, CA  Save This Job

Manager, Medical Information

Relypsa

Company Overview Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The

4/12/2016  Redwood City, CA  Save This Job

Rare Disease Manager (3621)

Aegerion Pharmaceuticals, Inc.

Req Id 3621 - Posted 05/05/2016 - United States - New Jersey - Newark - Sales ? Job Description Print Preview Apply Apply using LinkedIn? Save Job Email Job to Friend Return to List The field based Rare Disease Manager will be responsible for preparing the market,

5/17/2016  Newark, NJ  Save This Job