Regulatory Affairs Consultant

Location:

Kraków – Poland

Salary:

€0 per hour

Type:

Contract

Start Date: 

2024-09-09

Contract Period: 

12 Months

Main Industry:

Search Science Jobs

Advertiser:

ACHIEVA Group Limited

Job ID:

131075048

Posted On: 

10 September 2024

Regulatory Affairs Consultant  

– Possible Activities (all to be defined):
– Developing and implementing global regulatory strategies for simultaneous marketing authorisation submissions in the GCI, emerging markets and non-EU markets (including innovative / accelerated strategies). (This will be a shared responsibility with our submissions managers and require close partnership).
– Identifying risks and mitigations to protect business interests / avoid timeline slippage.
– Working closely with the submissions manager to prepare detailed regulatory plans for individual country filings, i.e. submission, questions, meetings, approval, etc. Identifying crunches in timelines for submissions and response to questions to help the global filing teams with planning for resource management.
– Leading the global filing team to generate additional country specific datasets / analyses, updating core documentation, and coordinating document review.
– Adaptation of core dossier contents for country submissions again in collaboration with the submissions coordinator and / or finalisation of Module 1 documentation in partnership with the GRL, regional and local regulatory teams where needed.
– Work with the GRL and cross functional filing teams within our client’s systems (Veeva vault) to prepare and check the local country filings and approve content plans / submissions – working with the regional and local regulatory teams. Follow our client’s process and policies.
– Coordinating the filing teams to plan for and generate RTQs (in parallel with priority markets) with re-use existing RTQs if possible: Specifically, to provide strategic guidance to the global filing teams re. the regulators question and guide the team to prepare high quality responses. Set up global filing team meetings, draft responses, coordinate reviews and approvals.
– Coordinate teams to prepare for pre-submission meetings and review meetings during the filing reviews in each market: Specifically providing strategic guidance to the cross functional filing teams to prepare for each meeting using their experience with these regulators.
– Suggest and coordinate any innovation in regulatory procedures to increase opportunity for acceleration.
– – Work closely with the local and regional regulatory leads on all aspects of marketing review and approvals.
– – Communicate issues and risks, approvals to management (via GRL).
– – Manage routine MA maintenance activities (for centralised procedure) as required.

EU based consultants ONLY – No UK based candidates please. 

Long term contract, initially 12 months to start ASAP. Full time, fully remote. 

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