Senior Associate – Regulatory Affairs (EU-OTC)

<p><strong>Submission support:</strong></p> <ul> <li>Submission management support for MRP &amp; DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc.</li> <li>Support for the registration of OTC drugs in EU countries.</li> <li>Support regional RA team to compile submission packages.</li> <li>Prepare cover letter, application form and relevant Module 1 documents for variations.</li> <li>Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA.</li> <li>Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing.</li> <li>Work with regional regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.</li> <li>Regulatory review of submission documents for compliance.</li> <li>Work with cross-functional teams or LRA’s for submission documents and verification of packages.</li> <li>Updating relevant submission tracker i.e. J tracker, HAQ tracker, PSMF tracker etc.</li> </ul> <p>&nbsp;</p> <p><strong>Renewal support:</strong></p> <ul> <li>Tracking of licenses for registration and approval.</li> <li>Tracking of approval validity of licenses and renewal timelines.</li> <li>Planning for renewal submission.</li> <li>Co-ordination with cross-functional team for Renewal documentation.</li> <li>Co-ordination with Local RA lead for Renewal documentation and submission.</li> <li>Preparation of Renewal package.</li> <li>Submission of Renewal to health authority and post submission activity.</li> </ul> <p>&nbsp;</p> <p><strong>CFI support:</strong></p> <ul> <li>Review and edit the consolidated CFI independently and with applying critical thinking and common sense</li> <li>Make sure that all the regulatory actions provided in the consolidated CFI fit for purpose (i.e. meet requirements of <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fscientific-guideline%2Fguideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report-superseded_en.pdf&amp;data=05%7C02%7CVijay.s%40clinchoice.com%7C307de60c9ba2475eea0b08dd19f38a5c%7Cd4d2cdf1c0824167839b468cd007d351%7C1%7C0%7C638695255992561516%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=qV4Kks4je1r0NiziNhRXhYAvUliSSe4gYjqm77qxmoA%3D&amp;reserved=0">GVP module VII.B.5.1 to 4</a>) and are written in such a way that it can be directly copied into the aggregate report</li> <li>Challenge LOC if their contribution is not appropriate</li> <li>Review the regulatory contribution in the draft and final aggregate report based on the outcome of the consolidated CFI</li> <li>Submit the PSUSA and follow until completion</li> <li>Submit the post PSUSA variations</li> </ul> <p>&nbsp;</p> <p><strong>Experience/Qualifications:</strong></p> <ul> <li>Minimum B.S. Chemistry, Biology, or related fields</li> <li>Minimum of 4 ~ 5 years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, 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.</li> </ul> <p>&nbsp;</p>