Regulatory Affairs Consultant - Biologics

September 30

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

Requirements

• 8-9 yrs 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.