Regulatory Affairs Specialist II

  • location: Bridgewater, NJ
  • type: Contract
  • salary: $39.38 - $46.33 per hour
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job description

Regulatory Affairs Specialist II

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. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Bridgewater, New Jersey
job type: Contract
salary: $39.38 - 46.33 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Global Business Unit (GBU).
  • He/she is responsible for developing long and short-term regulatory strategies for the projects and products under his/her accountability.
  • The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products.
  • The GRTL will determine regulatory requirements and options for global submissions/approvals and present the regulatory registration strategy to project team in line with the disease prevalence and commercial assessment of target product profile
  • The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
  • Lead Global regulatory Team (GRT) by providing project background and updates
  • Seek feedback from GRT on regulatory expertise knowledge of each specific area (i.e labelling, regional, publishing etc)
  • Plan GRT activities pertaining to project timelines
 
qualifications:
  • Degree in science (BS/MS)
  • Regulatory experience with projects in development
  • Looking for someone who adapts quickly, flexible and embraces change, looks for solutions on own with some guidance, positive mindset, multitasking, honest/transparent
  • Years of Experience: 3 - 6 Years
 
skills: Regulatory Affairs Operations
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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