Regulatory Affairs Associate - US post approval

Teva Pharmaceuticals

4 - 9 years

4 - 9 Lacs

navi mumbai

Posted:2 weeks ago| Platform:

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Skills Required

regulatory affairs change control assessment us post approvals supplements annual reports

Work Mode

Hybrid

Job Type

Full Time

Job Description

Role & 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 managements 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 guidances to understand and accurately assess change controls.
When needed, train Associate Is on internal processes, procedures, databases and trackers.
Other projects and duties as required/assigned

Preferred candidate profile

M. Pharma degree in RA/QA discipline, a plus.
4 to 10 years relevant experience in Regulatory Affairs with US Post approval
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

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