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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's4/24/2016 San Diego, CA Save This Job
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 direct5/25/2016 Bothell, WA Save This Job
Position Summary The Manager of Regulatory Affairs is accountable for the preparation and management of simple and complex regulatory submissions. They will act as liaison between Regulatory Affairs and other functional areas on various projects including external CROs, partners,5/26/2016 Cambridge, MA Save This Job
Manager - Regulatory Affairs (United States; Russia; Egypt; Turkey; UAE; Israel; Saudi Arabia) Responsibilities Manager positions will be responsible for administering the day-to-day Regulatory Affairs operations. Responsibilities may include: Directly or indirectly managing6/15/2016 Westborough, MA Save This Job
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, a5/17/2016 Redwood City, CA Save This Job
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 muscle5/9/2016 South San Francisco, CA Save This Job
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 may5/15/2016 Schaumburg, IL Save This Job
Location:Audubon, PA Job Code:RAPMKB0515 Description The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.6/22/2016 Audubon, PA Save This Job
Engineering ? Bellevue, Washington The Role: As an Ossia Senior Regulatory Program Manager, you will be responsible for spearheading certification effort for this new breakthrough technology. This role requires expertise in US and international regulatory processes, RF and6/13/2016 Bellevue, WA Save This Job
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 an4/24/2016 Pleasanton, CA Save This Job
inShare Location: Blue Ash, OH Aprecia is a specialty pharmaceutical company committed to transforming customers' experience with highly prescribed high-dose medications. Built upon our proprietary three-dimensional printing (3DP) technology platform, we develop and6/7/2016 Blue Ash, OH Save This Job
Department: Regulatory Affairs and Quality Assurance Hiring Manager: Director of Regulatory Affairs Summary of Position: Under the direction of the Director of Quality Assurance, the Manager/Associate Director GMP QA is responsible for providing QA and Technical support to6/6/2016 Boston, MA Save This Job
Clinical Operations Cambridge, MA, United States Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to6/21/2016 Cambridge, MA Save This Job
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 Collaborate5/22/2016 Cambridge, MA Save This Job
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
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,5/7/2016 San Francisco, CA Save This Job
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 will5/9/2016 Redwood City, CA Save This Job
This newly created position reports to the Director, Quality Assurance Compliance and is responsible for assuring GCP compliance with Alder SOPs, ICH and FDA/EMA regulations. Specific responsibilities will include: Provide GCP compliance support: participate in Clinical Project6/24/2016 Bothell, WA Save This Job
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 chosen5/22/2016 Davis, CA Save This Job
Career Opportunities: Rare Disease Manager - NY Metro (3541) Req Id 3541 - Posted 06/15/2016 - United States - New York - New York City - Sales The field based Rare Disease Manager will be responsible for preparing the market, educating customers and ultimately performing6/22/2016 New York, NY Save This Job