Regulatory Affairs Consultant (Biologics)
India, Remote Job ID R0000028027 Category Regulatory / Consulting Date Posted 11/15/2024Overview
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
Job Description:
- 8-9 yrs experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
- Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Support affiliates in updating local requirements based on guidance from regulatory agencies and input from affiliates/distributors.
- Strong understanding of local and international regulatory guidelines.
- Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products for filing in Regulated, Emerging and EU.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills. Ability to work independently.
- Effective communication and collaboration skills.
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