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Regulatory Affairs Operations Specialist II

2 months ago

Round Lake, Illinois, United States Experis Full time


Our client, a prominent player in the Healthcare sector, is seeking a Regulatory Affairs Operations Specialist II.

In this role, you will be tasked with executing intricate global regulatory strategies, securing and upholding marketing authorizations for products, and conveying essential regulatory requirements to facilitate the licensing of products.


Position Title:
Regulatory Affairs Operations Specialist II

Location:
Round Lake, IL

Key Responsibilities:
The following outlines the primary duties associated with this position. Additional responsibilities may be assigned as necessary.

  • Develop and initiate comprehensive regulatory project plans.
  • Identify and assess critical areas of regulatory risk.
  • Stay informed on relevant regulatory requirements.
  • Establish and maintain regulatory documentation in compliance with standards.
  • Offer regulatory guidance to project teams.
  • Address complex inquiries from regulatory bodies within specified timelines.
  • Compile and submit regulatory documents promptly in accordance with regulations.
  • Update and maintain existing regulatory authorizations.
  • Oversee regulatory activities for a designated portfolio of products/projects.
  • Prepare, review, and approve labeling and standard operating procedures (SOPs).
  • Lead or represent Regulatory Affairs in project teams.
  • Provide mentorship and guidance to junior team members in relevant areas.

Qualifications:

To excel in this position, candidates must demonstrate the ability to fulfill each essential duty effectively.


N/A:
Intern or Co-op

  • Understanding of regulatory frameworks.
  • Scientific expertise.
  • Project management capabilities.
  • Ability to manage multiple projects and meet deadlines.
  • Proficient in multitasking and prioritization.
  • Strong interpersonal and communication skills.
  • Effective negotiation abilities.
  • Technical proficiency in systems such as word processing, spreadsheets, databases, and online research.
  • Capability to work efficiently in a multinational and multicultural setting.
  • Skill in identifying compliance risks and escalating issues as needed.

Education and Experience:

Necessary qualifications for successful job performance include:

N/A:
Intern or Co-op

A Bachelor’s degree or equivalent in a scientific field
A minimum of 5 years of regulatory experience within a pharmaceutical organization for medicinal products, clinical research organization (CRO), or a similar entity, with a solid understanding of FDA regulations.


If this opportunity aligns with your career goals and you wish to learn more, please express your interest, and a recruiter will reach out to discuss this exciting position.

We look forward to connecting with you.



About Experis:

Experis, a part of ManpowerGroup, is a leading global workforce solutions provider, assisting organizations in navigating the evolving landscape of work by sourcing, assessing, developing, and managing the talent necessary for success.

We deliver innovative solutions to numerous organizations annually, connecting them with skilled talent while facilitating meaningful employment for millions across diverse industries.

Our family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - adds significant value for candidates and clients in over 75 countries and territories, a legacy built over 70 years.

We are consistently recognized for our commitment to diversity, being acknowledged as a top workplace for Women, Inclusion, Equality, and Disability. In 2022, Experis was honored as one of the World's Most Ethical Companies for the 13th consecutive year, affirming our position as the preferred brand for in-demand talent.