Regulatory Affairs Associate II

Watson Pharama

Posted: 3 months ago
Openings: 10
Applicants: 0

Job Description

Our Team, Your Impact

The Associate II, with moderate to minimal guidance, prepares, reviews and submits high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines. The Associate II will be responsible for independently evaluating change controls (intended for post approval changes), will assure the CC is complete and accurate and will consult his/her manager/designee prior to progressing the CC. In addition, he/she will accurately populate and maintain any/all Regulatory or team databases and trackers in real time, as directed by their Manager or Designee. Annual reports, supplements and post approval submissions will be the primary responsibilities of the Associate II.

How You'll Spend Your Day

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

Your Skills and 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

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.