Regulatory Affairs Specialist

  • location: Cambridge, MA
  • type: Contract
  • salary: $83.42 - $98 per hour
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job description

Regulatory Affairs Specialist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilize Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $83.42 - 98.00 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Our Company believes there is tremendous potential to do more to meet patients' and health care providers' expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. The Head, Global Regulatory Affairs Strategy, Plasma-Derived Therapies Business Unit will have the ability to create and define the future vision and operating model for the team. There will be two main drivers of innovation in the newly-formed PDT R&D group:
  • Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It will combine translational research with pharmaceutical sciences and device, and will receive inputs from and into clinical research and manufacturing sciences.
  • Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.

    Under supervision by the Lead, CMC Regulatory Affairs, Plasma-Derived Therapies Business Unit (GRA PDT BU) the Contractor is responsible for supporting the CMC Regulatory Affairs team in developing, coordinating and implementing global CMC regulatory strategies for assigned programs and tasks. Specifically, the Contractor is supporting the CMC Regulatory Affairs team in defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets
 
qualifications:
  • B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 4 years experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.
  • Experience in directing interactions with regulatory authorities desired.
  • Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
  • Significant coordination with cross-functional teams internally and regulatory authorities externally.
 
skills: CMC, FDA, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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