Regulatory Affairs Associate

Contract: North Chicago, Illinois, US

Salary: $30.00 Per Hour

Job Code: 351410

End Date: 2024-12-30

Days Left: 26 days, 23 hours left

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $28 to $30/hr. (negotiable)


Job Description:
Job Roles & Responsibilities:

  • Support Regulatory submissions for Food, FSMP, Enteral Nutrition, IF & FUF, Drug for EURI/ MENAP/ global. Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, amendments, etc …
  • Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes
  • Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
  • Participates/ Awareness on project plans, regulatory submission strategy, any risks management.
  • Advises project teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
  • Partner with other regulatory functions for smooth project transition and launch.
  • Support review of change controls to determine the level of change and consequent submission requirements
  • Support pulling reports, metrics related to submissions and approvals.
  • Offers country specific regulatory support
  • System VEEVA experience is helpful

 

Stakeholders:

  • Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project Management, Strategic Area and other stakeholders such as Project managers, Manufacturing Plants, affiliates, R&D, Technical center & Product Developers.

 

Skills/Experience Requirements:

  • Prior experience (2-3yrs) and Bachelor’s degree in nutrition/science related field.
  • Good understanding and working experience in different regulatory environment in multiple countries.
  • Experience in registration filing process of new nutrition products preferred.
  • Knowledge and understanding of formulation & scientific aspects of nutritional products.
  • Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
  • Adaptable in cultural and political diversity.
  • Capacity to learn and challenge status quo.
  • Team player
  • Self-motivated.

 

Job Requirement
  • Regulatory Affairs Associate
  • Regulatory Affairs
  • Regulatory Affairs Specialist
  • Regulatory Submission
  • Pharmaceutical
  • Food Science
  • Product Registration
  • dossiers
  • Nutrition Science
  • Biotechnology
  • Pharma
  • Pharmaceuticals
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • chitrank.rastogi@collabera.com
  • 4255231648
Apply Now
Apply Now
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