The Client has scientific and clinical programs originated in anti-infective technologies designed to prevent the spread of infectious disease by blood transfusions. As the result of a 2005 merger, the company expended its pipeline into novel, high val...

Regulatory Affairs Associate JO#514CP (Job Title and Job Code Number respond with this info) Job Description and Job Requirements: Our client seeks candidate with BS Chemistry and 5+ years experience directing regulatory affairs and submissions ...

Basic Function: Reports to the Director of Regulatory Affairs Regulatory Activities: Will be in charge of the ANDA file room and responsible for organization of volumes Will be responsible for filing of FDA let...

Regulatory Activities: Will be in charge of the file room and responsible for organization of volumes Will be responsible for filing of FDA letters, supplements, amendments, etc. Will prepare and submit drug listing forms t...

Reporting directly to the Vice President RA/QA, the position will focus primarily on the implementation of regulatory strategies in support of company initiatives, including but not limited to creation, preparation, and achievement of regulatory submissio...

Senior Regulatory Affairs Specialist is responsible for domestic and international submissions. ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned. ¢ Provide regulatory support of product project teams (e.g....

Responsible for managing 6 reports and representing company on all regulatory issues involving the following regulatory agencies: FDA, DEA, ATF, OSHA, EPA, and State Boards of Pharmacy. Prepares and submits regulatory submissions or filings which includes...

• Prepare regulatory submissions and filings on behalf of Paddock, such as applications, amendments, supplements, annual reports, annual reports, deficiency letter responses, drug listings, adverse experience reports, license renewals, registrations, repo...

SME – Regulatory Affairs First Consulting Group (FCG) is a provider of enterprise technology services, products and solutions to the Healthcare and Life Sciences community. We provide Enterprise Content Management Solutions (ECM) and offer FirstDoc®, the...

THE MANAGER FOR REGULATORY AFFAIRS WILL HAVE GLOBAL RESPONSIBILTY FOR THE REGISTRATION OF A COMBINATION PRODUCTS FOR CANCER, IMMUNE AND GENE THERAPIES. THE MANAGER FOR REGULATORY AFFAIRS WILL REPORT TO THE SENIOR DIRECTOR FOR CLINICAL AFFAIRS AND BE AN I...

Key role in developing global regulatory strategies, leading the reg process for new products from filing to approval. Special duties: Effectively contribute as the regulatory rep on project teams, facilitate responses to regulatory queries, input into th...

MISSION STATEMENT: The Regulatory Affairs Manager develops strategies for worldwide governmental approval to introduce new products to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The ...

2 positions available Mission Statement: Responsible for worldwide product submissions, perform label reviews, advise personnel on worldwide regulatory issues and assist in facility inspections Position Responsibilities: • Prepare and submit world...

Our client is a well-respected manufacturer of high quality medical equipment for the critical care and home care markets. The Director of Regulatory Affairs for the United States reports to the Vice President of Process, Quality and Regulatory. Cur...

Reports to Executive Director. Will have daily interaction with Sr. Management. Will manage several managers and associates. Must have ANDA submissions experience and 7+ years of regulatory affairs experience....