PTS Advance is actively hiring a Regulatory Specialist for our industry leading pharmaceutical client outside of Kansas City, KS. Our client has a mission to develop new and innovative ideas, utilize technology, and share their experience globally. Grow your career in Regulatory Affairs as a part of a company that is continuing to offer remarkable products and services.

We are searching for a talented individual who can share their knowledge of the regulatory environment in pharmaceuticals.

An Abbreviated List of Duties:

• Offer regulatory guidance and assesses labeling changes.
• Aids in meeting preparation.
• Ensures data meets regulatory guidelines.
• Work cross-functionally with external business partners, clients, and internally with relevancy to regulatory affairs as it pertains to labeling.
• Aid in the preparation and tracking of submissions, updates, reports, and other documents to clients.
• Communicate and collaborate as needed with FDA or other health authorities. Organize and deliver required documentation.
• Other duties as needed by management.

Key Skills

• Must be detail-oriented with excellent organizational and time management skills.
• Ability to complete regulatory tasks independently, accurately, and timely.
• Demonstrates strong knowledge of FDA regulations and guidelines. Knowledge of cGMPs.
• Familiar with ANDAs, INDs, or NDAs.
• Works well collaboratively; a team player.
• Ability to offer guidance and make needed recommendations.
• Excellent verbal and written communication skills.
• Strong use of computer skills.

Requirements

• Must have a Bachelor's Degree in Biology, Chemistry, or related life-sciences field.
• Minimum of 3 years in the Pharmaceutical Industry.
• Minimum of 2 years specializing in Regulatory Affairs.
• Understanding of Current Good Manufacturing Practices and FDA guidelines.

We are actively interviewing! Please follow the listed steps or send your resume to Brittany.antonellis@ptsadvance.com to apply.