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Manager Regulatory Affairs Jobs

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Manager - Regulatory Affairs

Sciformix Corporation

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 managing

6/15/2016  Westborough, MA  Save This Job

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

5/17/2016  Redwood City, CA  Save This Job

Sr. Manager, Regulatory Affairs

Zogenix, Inc.

Department: Regulatory Affairs Position Type / FLSA Status: Full Time / Exempt Location: Emeryville, CA Position Summary This position is primarily responsible for managing regulatory activities that support department and company projects and programs. This position will

6/28/2016  Emeryville, 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

5/15/2016  Schaumburg, IL  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

5/29/2016  San Diego, CA  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

5/9/2016  South San Francisco, CA  Save This Job

Regulatory Affairs Specialist (U.S.)

Globus Medical

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

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

5/25/2016  Bothell, WA  Save This Job

Regulatory Affairs Manager

Genocea Biosciences, Inc.

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 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

5/9/2016  Redwood City, CA  Save This Job

Associate Director, Regulatory AffairsEmail

Aprecia Pharmaceuticals

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 and

6/7/2016  Blue Ash, OH  Save This Job

Manager/Associate Director GMP QA

Paratek Pharmaceuticals

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 to

6/6/2016  Boston, MA  Save This Job

Sr. Clinical Supply Manager

Merrimack Pharmaceuticals

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 to

6/21/2016  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?

5/29/2016  Boston, MA  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

5/22/2016  Cambridge, 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,

5/7/2016  San Francisco, CA  Save This Job

Senior Regulatory Program Manager

Ossia, Inc.

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 and

6/13/2016  Bellevue, WA  Save This Job

Senior Manager, GCP Compliance

Alder Biopharmaceuticals

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 Project

6/24/2016  Bothell, WA  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

5/22/2016  Davis, CA  Save This Job

Rare Disease Manager - NY Metro (3541)

Aegerion Pharmaceuticals, Inc.

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 performing

6/22/2016  New York, NY  Save This Job