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

Parexel, a global leader in regulatory consulting, is hiring a Regulatory Affairs Associate (Biologics) to support biopharmaceutical companies in navigating the complex regulatory landscape. This remote role offers you the opportunity 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 the perfect role for you!

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 pre- and post-approval life cycle activities for biologic products 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:

• Education: Bachelor’s or Master’s degree in life sciences, pharmacy, or a related field.
• Experience: 4-6 years of experience in regulatory affairs, particularly in biologics, with a proven track record of managing pre- and post-approval submissions.
• Familiarity with regulatory frameworks for regulated and emerging markets.
• Strong understanding of regional and international regulatory trends.
• Ability to work independently and manage multiple tasks with a high level of attention to detail.
• Excellent communication skills and the ability to collaborate effectively with global teams.
• Knowledge of regulatory management systems such as Veeva Vault.

Application Process

Apply now for the role of Regulatory Affairs Associate (Biologics) through Parexel Career page Below

Apply here: Parexel Careers