Regulatory Affairs Associate II

Job Description:

Responsibilities

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Under minimal supervision, proactively request documentation required for annual reports, compile and publish for managements review.
• Under management’s direction/assignment, work independently on simple supplements, compile and publish for managements review. Assist management on more complex supplement to gain experience.
• Further educate oneself on FDA Regulations by reviewing any/all applicable post approval guidance’s to understand and accurately assess change controls.
• When needed, train Associate I’s on internal processes, procedures, databases and trackers.
• Other projects and duties as required/assigned

Qualification & Experience

• M. Pharma degree in RA/QA discipline, a plus.
• Minimum four years plus pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred.
• Basic computer skills such as Word, Excel and familiarity with the internet
• Ability to work independently and on teams
• Good verbal and written communication skills
• Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities