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Manager Regulatory Affairs Jobs

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Manager, Regulatory Affairs

Sagent Pharmaceuticals

Location: Schaumburg, IL, USA Manager, Regulatory Affairs Department: Regulatory Affairs Reports To: Sr Manager, Regulatory Affairs AND/OR Associate Director Regulatory Affairs Job Summary / Overview: The role is primarily responsible for the management and support of Pre

7/4/2015  Schaumburg, IL  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

8/5/2015  Redwood City, CA  Save This Job

Manager, Regulatory Affairs (EMEA) (1241)

Aegerion Pharmaceuticals, Inc.

The Regulatory Affairs Manager will be responsible for the preparation of CTDs and associated filings in the EU, and will also support international filings as needed. The incumbent will be responsible for managing, evaluating and completing regulatory projects consistent with

8/11/2015  Cambridge, MA  Save This Job

Group Manager, Regulatory Affairs

Globus Medical

Location:Audubon, PA Job Code:GMRAKB0415 Description The Group Manager, Regulatory, is responsible for preparing, submitting and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products, and to

7/12/2015  Audubon, PA  Save This Job

Associate, Regulatory Affairs, Labeling

Sagent Pharmaceuticals

Location: Schaumburg, Illinois Job Title: Associate, Regulatory Affairs (Labeling) Department: Regulatory Affairs Reports To: Manager ,Regulatory Affairs Job Summary / Overview: As directed by the Manager, Senior Manager or Senior Associate, responsible for the support of

8/3/2015  Schaumburg, IL  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

7/12/2015  Audubon, PA  Save This Job

Manager of Regulatory Affairs and Market Development

FirstFuel Software

Stage 3: Beta Test / Clinical Trials 

ID 2015-1042 # of Openings 1 Location FirstFuel Posted Date 4/7/2015 Category Sales More information about this job: Overview: FirstFuel is seeking a Manager of Regulatory Affairs and Market Development to expand its coverage, understanding, and influence within utility

6/30/2015  Lexington, MA  Save This Job

Regulatory Affairs Manager (15-585)

MacroGenics

Job Code: 15-585 Location: Rockville, MD Applicants must meet the following requirements: Minimum of Bachelor?s degree in scientific discipline; advanced degree desirable Minimum of 5 years of Regulatory Affairs experience with at least two years in industry, preferably with

8/21/2015  Rockville, MD  Save This Job

Senior Drug Product Manufacturing Manager (1201)

Aegerion Pharmaceuticals, Inc.

The Senior Manager, Drug Product Manufacturing will report into the Director, Drug Product Manufacturing. This individual will be responsible for leading formulation, process development and clinical manufacturing efforts for drug products in clinical development as well as

8/11/2015  Cambridge, MA  Save This Job

Senior Manager, Pharmaceutical Process Development and Clinical Manufacturing

GlycoMimetics

Reports to: Senior Director, Manufacturing and Non-Clinical Operations Job Code: 2015 -70-4 Job Summary The Senior Manager, Pharmaceutical Process Development and Clinical Manufacturing manages the transfer and scale-up of synthetic chemical processes and sterile drug product

7/28/2015  Gaithersburg, MD  Save This Job

Clinical Supply Manager

Merrimack Pharmaceuticals

Product Supply Cambridge, MA, United States Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack seeks to gain a deeper understanding of

7/11/2015  Cambridge, MA  Save This Job

Quality Assurance Manager (701)

Aegerion Pharmaceuticals, Inc.

The QA Manager is responsible for oversight of selected quality systems and contract manufacturing (CMO), packaging and testing activities. Act as primary quality contact/liaison with CMO quality organizations. Serves as product quality representative on cross functional project

8/11/2015  Cambridge, MA  Save This Job

Quality Systems Manager

High Throughput Genomics

Job Location Tucson, Arizona Essential Duties Responsible for the maintenance and improvement of key Quality systems and processes as well as insuring those quality requirements are defined and met during design, development and release to manufacturing. The incumbent will work

7/20/2015  Tucson, AZ  Save This Job

Program Manager

Merrimack Pharmaceuticals

Clinical Development Cambridge, MA, United States Merrimack Pharmaceuticals is a high-energy biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an

7/11/2015  Cambridge, MA  Save This Job

Manager, Clinical Operations

Acceleron Pharma

About Acceleron: Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth

7/25/2015  Cambridge, MA  Save This Job

Regulatory Manager

Glooko

Stage 4: Shipping Product $20 - 50M raised$20 - 50M raised$20 - 50M raised

Glooko Inc. is looking for a Regulatory Manager in its Palo Alto office to perform regulatory compliance and submission functions. Job Duties ? Regulatory Compliance Functions o Conduct pre-audit readiness, lead audits, address inspection findings, and develop/implement

6/30/2015  Palo Alto, CA  Save This Job

Manager Process Chemistry

Verastem

Posted on 7/01/2015 Verastem, Inc. (NASDAQ: VSTM) is a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis.

7/25/2015  Needham, MA  Save This Job

Senior Manager, Drug Safety Quality Lead

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

8/5/2015  Redwood City, CA  Save This Job

Manager, Pharmacovigilance

Acceleron Pharma

About Acceleron: Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the TGF--- protein

7/25/2015  Cambridge, MA  Save This Job

Clinical Research Project Manager

Globus Medical

Location:Audubon, PA Job Code:CRPMGJ0415 Description The Project Manager, Clinical Research will be responsible for conducting post marketing clinical research on Globus Medical products. The candidate should have demonstrated abilities to conduct clinical trials and work with

7/12/2015  Audubon, PA  Save This Job