Regulatory Affairs Consultant (Biologics)

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.