Senior Regulatory Affairs Specialist at Piper Companies
Pennsylvania, Pennsylvania, USA -
Full Time


Start Date

Immediate

Expiry Date

04 Dec, 25

Salary

120000.0

Posted On

04 Sep, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

Piper Companies is seeking a Senior Regulatory Specialist to join an organization in Philadelphia, PA. A Senior Regulatory Specialist will provide planning, engineering, implementation, monitoring and analysis of endpoint security systems.

QUALIFICATIONS FOR THE SENIOR REGULATORY SPECIALIST:

  • Understanding of regulatory terminology, submission types and requirements as well as ability to evaluate regulatory impact of proposed products
  • Multi-task skills as well as ability to project plan and be result driven
  • Bachelor’s degree and 5 years of experience
  • Master’s degree and 3 years of experience
Responsibilities
  • Coordinate and prepare document packages ensuring compliance with local and regional registration requirements
  • Complies to all materials required in submissions and recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. As well as monitors and improving tracking and control systems
  • Collaborates with various departments to review the required plans, procedures, and regulatory decisions for existing products
  • Review technical publications, articles, and abstracts to stay up to date on regulatory and technical developments in the industry as well as support product import by providing regulatory documentation and certifications
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