Note: The job is a remote job and is open to candidates in USA. Parexel is a leading company in the field of regulatory affairs, and they are seeking a Regulatory Affairs Consultant to manage post-approval regulatory activities. The role involves partnering with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.
Responsibilities
- 7+ 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 transfer’s, Article 31 & other post approval variations & MAA’s
- 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
Skills
- 7+ 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 transfer's, Article 31 & other post approval variations & MAA's
- 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
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