Work from Home Regulatory Affairs Associate (Biologics) Hiring at Parexel

Parexel, a global leader in regulatory consulting, is hiring a Senior Regulatory Affairs Associate (Biologics) to help biopharmaceutical companies navigate the complex regulatory landscape. This remote role allows you to work from anywhere in India while engaging in high-impact regulatory work. If you have a passion for regulatory science and biologics, this could be your perfect role!

Job Overview: Regulatory Affairs Associate (Biologics)

As a Regulatory Affairs Associate (Biologics) at Parexel, you will play a crucial role in the regulatory process for biological products across various global markets, including the EU, US, and emerging regions. Your expertise will help ensure the timely submission and approval of applications, allowing innovative biologics to reach patients faster.

Key Responsibilities:

• Manage biologic products’ pre- and post-approval life cycle activities in regulated and emerging markets.
• Prepare and review Marketing Authorization Applications (MAA) and variations for submission in regulated markets (EU, US, Canada).
• Compile and submit Life Cycle Management (LCM) documentation and post-approval changes to regulatory agencies.
• Ensure compliance with local and international regulatory guidelines by working closely with cross-functional teams.
• Utilize regulatory information management systems like Veeva Vault to manage submissions and track regulatory updates.
• Collaborate with global teams to develop and implement regulatory strategies.
• Provide status updates and ensure timely submissions to the relevant stakeholders.

Qualifications & Skills Needed

To excel in this role, Parexel is seeking candidates with the following qualifications and skills:

• Senior Regulatory Affairs Associate ( Biologics )
  • 4 to 8 years of experience authoring, compiling and submitting country-specific submission files (MAA and post-approval changes) of Biologic products in various markets – Regulated (EU/US/Canada) and Emerging Markets. 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.
  • Good understanding of regulatory guidelines and frameworks, including regional trends, for various types of applications and procedures. Working experience in Regulatory Information Management Systems like Veeva Vault.
  • Execute and maintain submission delivery and content plans and proactively provide status updates to designated stakeholders.
  • Strong communication and collaboration skills. Ability to work independently.

Application Process

Apply now for the regulatory Affairs Associate (Biologics) position through the Parexel Career page below.

Apply here: Parexel Career.s