Parexel BSc Jobs For Life Sciences – Apply Online
Parexel BSc Jobs For Life Sciences – Apply Online. Parexel Hiring BSc & MSc Life Sciences regulatory affairs associate vacancy. Parexel has job openings for biological sciences candidates. Check out all of the details on the same below
Designation – Regulatory affairs associate
Requisition ID – 82196BR
Location – India-Bengaluru
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.
Regulatory Affairs Associate-
- Relevant 2 or years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
- • To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
o Submission delivery strategy
o Review of documents
o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. - Liaise closely with cross-functional members with aligned product responsibilities.
- Develop, execute and maintain submission delivery plans, and submission content plans, and proactively provide status updates to designated stakeholders.
- Authoring the dossier sections based on the changes to the approved MA. Knowledge of change evaluation according to country guidelines Experience in managing lifecycle activities in the EU markets.
- Knowledge of CTD guidelines.
Education:
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences.
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