Regulatory Affairs Associate- Local Regulatory Affairs Operations

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

This role focuses on managing post-approval regulatory activities including variations renewals and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.

Key Responsibilities

2 yrs experience in support regulatory submissions including MAAs (Marketing Authorization Application) variations (minor/major) responses to questions renewals withdrawals and marketing authorization transfers.

Working knowledge on EU procedures including centralized procedures coordination and management.

Preparation and coordination for Module 1 activities for CMC Safety Administrative MA transfers Article 31 & other post approval variations & MAAs.

Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up

Manage submissions through local Health Authority portals as required

Handle post-approval lifecycle management activities and regulatory communication-RIMS

(Regulatory Information Management Systems)-VEEVA Vault

Support linguistic review processes including translation review and coordination

Conduct readability testing and support artwork (AW) review mock-ups and approvals

Support promotional material review including Abbreviated Product Information

(API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting)

Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.