Regulatory Affairs Consultant
Bengaluru, India Job ID R0000022455 Category Regulatory / Consulting Date Posted 07/04/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About 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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