Regulatory Affairs Specialist

Work set-up: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

At least 3 years of experience in a CMC or Module 3 regulatory role., Proficiency in Microsoft Office tools., Strong project management and planning skills., Knowledge of regulatory requirements in US, EU, and Japan..

Key responsibilities:

  • Lead global clinical trial and marketing authorization submissions.
  • Assist in creating and managing submission content and structure.
  • Coordinate communication between affiliates, scientists, and regulatory teams.
  • Ensure compliance with regulations to expedite product registration and lifecycle management.

Saviance Technologies Pvt. Ltd. logo
Saviance Technologies Pvt. Ltd. SME https://saviance.com/
51 - 200 Employees
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Job description


Title: Regulatory Affairs Specialist 1416

Location: Indianapolis, IN

Duration: 18+ Months

Description

Qualifications:

MUST REFLECT ON RESUME: 3+ years experience in a CMCChemistry Manufacturing and Controls position OR 3+ years Module 3 experience (regulatory app that is specific to CMC). Also Microsoft Office experience. Other requirements include: Soft skills of Project Mgmt and Project planning, seeing project from beginning to end, working with in the group, to ensure they are staying on task and able to meet deadlines, etc. Preferences Nice to haves include: Pharma exp specifically. Device experience would be helpful. Combination products experience, device regulatory experience. A good knowledge of regulatory requirements, specifically US, EU, and Japan.

Responsibilities:

The GRACMC Regulatory Associate leads, in partnership with the GRACMC RA Scientists, the various aspects of global clinical trial and marketing authorization submission management processes. The Regulatory Associate also partners with GRACMC Scientists to help create and manage submission content and provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidances and regulatory precedence. The Regulatory Associate will triage and manage the communications between our Lilly Affiliates, GRACMC Scientists, Specialists, and the QualityRegulatory Representatives. The Regulatory Associate utilizes GRACMC submission process expertise and their expertise with information technology tools to develop project management expectations across projects. The GRACMC Regulatory Associate will be responsible for routine communication of submission tracking requirements to both GRACMC Scientists and internal customers. The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with submission specialists and project management for clinical trials and marketed product support.


Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Microsoft Office
  • Teamwork
  • Ability To Meet Deadlines

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