EAEU Regulatory project coordinator KZ/CIS

Обязанности:

Regulatory database full management related to submission, including

Preparation, Publishing, Submission and Archiving LOC baseline dossier, uploading Modules 1, 2, 4 and 5 to the database for RMS dossier and Module 1 for CMS dossier. Dispatch final core dossier binder to RA LOC.

Confirm dossier team contacts and prepare Kick-off (K.O.) meeting slide deck, schedule Dossier Team K.O. meeting and regular fortnightly meetings, lead meetings, issue minutes.

Coordinate preparation of EN core dossier and subsequent responses to EAEU evaluations with RA LOC and Cross-functional team (RMS & CMS dossier submissions).

Follow-up on document requests and resolve or mitigate any emerging issues/risks with dossier team.

Review Non-clinical and Clinical module 2 documents in database.

Identify with CMC & RA LOC any remediation required prior to submission of re-baseline dossier and provide inputs into Project Plan.

Manage requests and the preparation of Module 1 core documents. Retro-planner template in SP includes those Modules that GRA is responsible for.

Review Module 1 prepared for earlier EAEU dossiers/search Reg database for any Module 1 documents we can re-use for a new dossier. Include review comments in the Project Actions-Minutes document.

Identify any updates required to Module 1 documentation following EAEU evaluations, Industry intelligence and maintain Module 1 & retro-planner templates in SP.

Author Module 2.2. Introduction and circulate via Reg database to RA LOC for review.

Request Reg Ops to cross link Module 4 and 5 Study Reports used for the first time and publish core dossier and archive.

Attend fortnightly Core Team Meetings (CTM) and Planning meetings. Update CTM agenda as track changes ahead of each CTM, and update EAEU Planner ahead of Planning meetings (both documents available in SP).

Liaise with Nitrosamines Taskforce and Separation Team, advising them of EAEU program milestones and identifying any RU or KZ RMS applications requiring coordination with the Nitrosamines Step 2 submissions.

Maintain dossier team functional contacts spreadsheet in SP.

Update retro-planner with status of m1 documentation and RIM numbers from reg database and any updated database numbers following RtQ.

Regularly review & monitor Milestone tracker and Risks Register together with RA LOC.

Coordinate and provide support to dossier team in preparing responses to validation or evaluation requests. Issue response binder to RA LOC.

Prepare comparative reviews of the RMS versus CMS SmPC and Normative Document and share with RA LOC. Identify any key differences and agree Regulatory strategy with RA LOC.

Prepare Module 1 for CMS submissions.

Work with AIPM (Russian Trade Association & other EAEU Trade Associations) to lobby EAEU Committee, gather any intelligence and provide updates to GRA and Dossier Team.

Liaise with QA LOC and Legal to prepare local Module 1 documentation.

Review CMC gap analysis and identify with CMC & GRA any remediation required prior to submission of re-baseline dossier and provide inputs into Project Plan.

Work with CMC to prepare any national variation data packages required to be filed prior to the re-baseline dossier.

Coordinate local translation of Modules 1 to 3.

Translate Validation & evaluation requests and share with Dossier Team.

Maintain dossier team functional contacts spreadsheet in SP.

Review & monitor Milestone tracker and Risks Register together with GRA. Identify potential project risks and mitigation.

Prepare responses to validation or evaluation requests, with the support of the GRA and dossier team.

Arrange User Test for multi-market package leaflet.

Dates for EAEU GMP site inspections/confirmation that product has been included in scope of inspection.
Preparation of Regulatory Strategy Document (RSD) for Dossier Team

Management of geo-expansion NPI projects for EAEU existing and absolutely new products

Требования:

Minimum Level of Education - BA or BSc
Area of Specialization - Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
Minimum Level of Job-Related Experience required - 3-5 years’ experience in Regulatory Affairs, however this is variable depending on availability of regulatory talent
Planning and organization skills
Strategic thinking
Negotiation skills -- experience working with different external Regulatory Authorities
Working knowledge of dossier requirements, CTD, eCTD, NeeS
Fluent written and verbal communication in English and Russian
Strong results driven abilities
Excellent interpersonal, time management, organizational and communication skills