Senior Associate – Regulatory Affairs (EU-OTC)

Submission support:

• Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc.
• Support for the registration of OTC drugs in EU countries.
• Support regional RA team to compile submission packages.
• Prepare cover letter, application form and relevant Module 1 documents for variations.
• 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 regional 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 LRA’s for submission documents and verification of packages.
• Updating relevant submission tracker i.e. J tracker, HAQ tracker, PSMF tracker etc.

 

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.

 

CFI support:

• Review and edit the consolidated CFI independently and with applying critical thinking and common sense
• Make sure that all the regulatory actions provided in the consolidated CFI fit for purpose (i.e. meet requirements of GVP module VII.B.5.1 to 4) and are written in such a way that it can be directly copied into the aggregate report
• Challenge LOC if their contribution is not appropriate
• Review the regulatory contribution in the draft and final aggregate report based on the outcome of the consolidated CFI
• Submit the PSUSA and follow until completion
• Submit the post PSUSA variations

 

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., 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.