Senior Associate / Specialist - CMC, EU-OTC

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.