Regulatory Affairs Consultant

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

• 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.