Regulatory Affairs Consultant (Biologics)
India, Remote 求人ID R0000028027 Category Regulatory / ConsultingAbout this Role
Job Description:
- 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.
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