Regulatory Affairs Scientist

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Regulatory Affairs Scientistand be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Regulatory Affairs Scientist, you will ensure the coordination and management of Quality/CMC regulatory documents related to all pre and post marketing activities in all regulatory jurisdictions. You will establish strong links with all involved departments and external partners, as applicable, to ensure dossiers are compiled, submitted, and approved in an efficient and timely manner. You will also coordinate the overall timeline of work and collaborate with both internal and external stakeholders. Additionally, you will:

  • Train and support other SMEs in Quality/CMC requirements within designated functional areas
  • Write and/or review technical Quality/CMC Regulatory documents for global regulatory submissions, ensuring compliance and alignment with global regulatory requirements and strategy
  • Lead special projects in coordination with internal and external stakeholders
  • Lead preparation and compilation of Quality/CMC portions of eCTD and non-eCTD global regulatory submissions and submission documents (may lead submission of delegated dossiers)
  • Present key Quality/CMC updates to regulations, guidelines, and processes, as delegated, to project team
  • Review and ensure documents follow correct Quality/CMC labelling content and formatting requirements

What You’ll Need to be Successful:

  • At least 7 years of experience in regulatory affairs
  • BS in a relevant field such as biological or chemical sciences
  • Excellent knowledge of global regulatory agencies, submission processes, and filing/approvals in relation to Quality/CMC document and dossier requirements
  • Broad knowledge of regulatory information system (RIM) and electronic document management system (EDMS)
  • Broad understanding of GLP, GMP, and GCP
  • Excellent oral and written communication skills
  • Excellent knowledge of Office Suite including Word, Excel, PowerPoint, and Project
  • Demonstrated ability to complete larger regulatory documents such as M2 summaries and overviews
  • Excellent understanding of global labelling requirements and ability to find regulatory material and information

Great Additional Skills:

  • RAC certification

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Wednesday, March 10, 2021



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  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.