Regulatory Affairs Consultant
Bengaluru, India 求人ID R0000022455 Category Regulatory / ConsultingAbout this Role
- 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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