Senior Associate / Specialist - CMC, EU-OTC

Job Description

A pharmaceutical company is seeking a Senior Associate / Specialist - CMC, EU-OTC. This role is based in India and focuses on regulatory affairs within the pharmaceutical sector. The Senior Associate/Specialist will be responsible for submission management support for MRP & DCP procedures, PSUSA submissions, renewals, repeat use procedures, and variations. They will prepare and compile regulatory documentation for the registration, variation, and renewal of OTC drugs for EMEA.Responsibilities include managing regulatory action item tables, coordinating regulatory inputs, and ensuring timely project completion. The role involves regulatory review of submission documents for compliance and collaboration with cross-functional teams and local affiliates. The candidate will also support PSUR submissions, track licenses, review draft PSUR documents, and coordinate with stakeholders for safety-related information.Renewal support includes tracking licenses, planning renewal submissions, coordinating with cross-functional teams, and preparing renewal packages. The Senior Associate/Specialist will provide regular project status updates, ensure regulatory standards and timelines are met, and utilize regulatory databases and IT tools.

• 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.
• 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.
• 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
• 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.

• 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.

• Weekly updates on project status
• Opportunity to work on diverse regulatory projects