Parexel Hiring for Regulatory Affairs Associate (Biologics) work from home

Parexel 4-6 years Not disclosed

Work From Home

As a Regulatory Affairs Associate at Parexel, you will play a crucial role in helping biopharmaceutical and medical device companies manage the regulatory landscape for biologic products. Your focus will be on pre- and post-approval life cycle management, ensuring products are brought to market swiftly and remain compliant with regulations in various regions.

Key Responsibilities:

Handle the regulatory life cycle management of biologic products in regulated markets (EU, US, Canada) and emerging markets.
Support the compilation, submission, and approval of country-specific regulatory files, including Marketing Authorization Applications (MAA) and Life Cycle Management (LCM).
Prepare and review regulatory submissions for various medicinal products, including post-approval changes and variations.
Ensure regulatory compliance by keeping track of regional guidelines and regulatory frameworks.
Collaborate with cross-functional teams, ensuring alignment on product responsibilities.
Execute submission delivery plans and maintain status updates for stakeholders.
Work with Regulatory Information Management Systems like Veeva Vault.

Qualifications:

Experience: 4-6 years of regulatory experience with biologic products.
Skills: Strong understanding of local and international regulatory frameworks and trends.
Communication: Effective communication and collaboration skills to work independently and within a team.