Regulatory Affairs Associate

2 months ago


Bengaluru, India Parexel Full time

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.

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