Regulatory Affairs Associate
2 months ago
When our values align, there's no limit to what we can achieve.
Job Description:
4-6 yrs of 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.-
Regulatory Affairs Associate
5 months ago
Bengaluru, India Parexel Full time**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...
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Regulatory Affairs Associate
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Senior Regulatory Affairs Manager
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Lead
4 weeks ago
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Regulatory Affairs Specialist
3 weeks ago
Bengaluru, Karnataka, India Baxter Full timeTransforming Healthcare, One Document at a TimeBaxter is a global leader in medical innovations, and we're looking for a skilled Regulatory Affairs Specialist to join our team.As a Regulatory Affairs Specialist at Baxter, you'll play a critical role in ensuring the accuracy and compliance of regulatory documentation for our medical products.Responsibilities...
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Regulatory Affairs Specialist
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