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.