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.
- Vacancy details:
- Department: Regulatory Affairs Consultant /Senior Regulatory Affairs Associate / Regulatory Affairs Associate
- Experience:Â 4-9 Years
- Job Description: Greeting From Parexel Private Limited !!!!!!!!
Important Details :
- Location: India-BengaluruÂ
- Post of date: 14/10/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Key competencies:
Experience and expertise in authoring, compiling and submission of country specific submissions (MAA, BLA, and post approval changes) of Biologics/ Biosimilar products in various markets- Regulated (EU/US/Canada) and emerging markets.
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.
Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.
Proficiency in Regulatory Information Management Systems like Veeva Vault
Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Strong communications and collaboration skills; Ability to work independently.
Walk in Drive :
Date 19th October, 2024
Venue – Bengaluru Office
Time 10:00 AM onwards
