Regulatory Affairs Consultant

1 month ago


Hyderabad, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

8+ years’ experience in handling life cycle management of approved drug products (like-Tablets, Syrups, Ointments, Nasal Sprays) for ROW markets. Working knowledge of ROW regulatory guidelines, including post approval requirements. Knowledge of ASEAN markets’ regulatory legislations would be an added advantage. Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and more complex regulatory maintenance submissions from either a global and/or regional perspective. Lead/Plan, prepare, review and strategize minor labelling variations & safety labelling variations across the ROW countries as per business requirements. Experience in handling CMC & labelling related health authority queries. Liaise closely with cross-functional members with aligned responsibilities and proactively provide status updates to designated stakeholders. Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable. Experience on Artwork Management Tools like Vista link would be an added advantage. Strong listening and communication skills would be desirable. Ability to work independently without the need to supervise.

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