Senior Associate / Specialist - CMC, EU-OTC

Job Description

Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. Work with cross-functional teams or local affiliates for submission documents and verification of packages. Updating relevant submission tracker. PSUR submission support: Review of EURD updates Tracking licenses for DLP and PSUR submission. Review of draft PSUR document for accuracy of the data. Co-ordinate with different stakeholders for safety related information for PSUR Support submission and handling of queries for PSUR Renewal support: Tracking of licenses for registration and approval. Tracking of approval validity of licenses and renewal timelines. Planning for renewal submission. Co-ordination with cross-functional team for Renewal documentation. Co-ordination with Local RA lead for Renewal documentation and submission. Preparation of Renewal package. Submission of Renewal to health authority and post submission activity. Deliverables: Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation] Ensure that regulatory standards and timelines are met for all projects. Planning and tracking the status of ongoing regulatory projects Use of regulatory database and IT tools where relevant. Project review every quarter on performance feedback and scope of improvement. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., parmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations. Show more Show less