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.
