Regulatory Specialist-REMOTE Job in Actalent Chicago, IL

Website Actalent

This Jobsfunter Listing is about Actalent in Chicago, IL 2022

About the job

  • Description:* Objectives
  • The Regulatory Affairs Specialist / Sr. Specialist handles all regulatory development aspects for prescription brand products. Active member on the product development team to provide regulatory guidance for Pharmaceutical Brand products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for assigned products.

Experience

  • 3+ years relevant pharmaceutical industry and regulatory experience
  • Pharmaceutical Rx (not generics) development strategy experience highly preferred
  • Medical device experience a plus
  • Bachelor’s degree in science or health related field Key Activities / Job responsibilities
  • Responsible for preparing, authoring submissions to health authorities
  • Liaises with regulatory counterparts to ensure regional requirements are incorporated into product strategy development
  • Develops a product regulatory timeline aligned to organization defined product development, with key regulatory milestones, and activities for health authority filings
  • Ensures labeling content and product documentation is developed in accordance with regulatory requirements
  • Participates as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
  • Coordinates with Regulatory Operations group to ensure timely and accurate submissions to Regulatory Authorities
  • Additional Skills & Qualifications:* Key Relationships
  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Strong capability to contribute and lead a team environment
  • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
  • Excellent communication skills; both oral and written
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Capacity to react quickly and decisively in unexpected situations
  • Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
  • Focused ability to influence operational excellence and performance metrics
  • Risk adverse where needed with the ability to identify potential solutions to complex problems
  • Qualifications*
  • Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Labeling, CMC, Commercialization, and Operations
  • Knowledge of domestic laws, regulations, and guidance that affect Brand products
  • Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
  • Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products
  • Ability to partner with cross-functional teams in a pharmaceutical organization
  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
  • Experience Level:* Intermediate Level Compensation is tied to the Colorado market for jobs performed in Colorado. Other locations may be subject to variances based on locations-related factors. We reserve the right to pay above or below the posted wagebased on factors unrelated to sex, race, or any other protected classification. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
  • Medical, dental & vision
  • 401(k)/Roth
  • Insurance (Basic/Supplemental Life & AD&D)
  • Short and long-term disability
  • Health & Dependent Care Spending Accounts (HSA & DCFSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company: Actalent

Vacancy Type: Contract · Entry level 

Job Location: Chicago, IL

Application Deadline: N/A

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