[Remote] Regulatory Affairs Consultant- Local Regulatory Affairs Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company 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 (reputed company reputed company reputed company Communication) reputed company 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)-reputed company Vault
- Support linguistic review processes including translation review and coordination
- Conduct readability testing and support artwork (AW) review, mock-reputed company, and approvals
- Support promotional material review including Abbreviated Product Information
- (API) creation or updates and Regulatory Affairs review processes (including UK reputed company-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 (reputed company reputed company reputed company Communication) reputed company 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)-reputed company Vault
- Support linguistic review processes including translation review and coordination
- Conduct readability testing and support artwork (AW) review, mock-reputed company, and approvals
- Support promotional material review including Abbreviated Product Information (API) creation or updates and Regulatory Affairs review processes (including UK reputed company-vetting)
- Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level
reputed company