100% REMOTE Regulatory Specialist - Remote | CareerCircle
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100% REMOTE Regulatory Specialist

Actalent

02/18/2022

Posting ID: JP-002656667

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Immediate need for Regulatory Affairs Specialist with prescription brand experience to joining rapidly growing pharmaceutical client! This position is 100% Remote and they are actively interviewing!

Description:

• The Regulatory Affairs Specialist / Sr. Specialist handles all regulatory development aspects for prescription brand (“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

**Quick Access to Benefits - Medical, Vision, Dental, 401(k) | Holiday Pay & 2 weeks of Vacation

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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.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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