Senior Regulatory Affairs Associate @ Parexel

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Senior Regulatory Affairs Associate

Parexel
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Bengaluru
4 years ago
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Job Description

Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries . Experience with ROW countries would be a plus.
Lead and / or contribute to the planning, 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.
Liaise closely with cross-functional members with aligned product responsibilities.
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable)
Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents
Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirableQualifications
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences

Employement Category:

Employement Type: Full time
Industry: Full time
Functional Area: Pharmaceutical
Role Category: IT
Role/Responsibilies: Senior Regulatory Affairs Associate

Contact Details:

Company: Parexel International
Location(s): Bengaluru

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Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

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Parexel

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter â€“ and keeping them there â€“your scientific, technical, regulatory, and/or commercial expertise will...

Senior Regulatory Affairs Associate @ Parexel

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