Regulatory Affairs Project Manager
- Experience Level
Compensation: Competitive total compensation.
We have a newly created vacancy for a permanent Regulatory Affairs Project Manager. You will be responsible for the management and coordination of regulatory operations for regulatory submission team with decentralised set up. In addition, you will be expected to manage the commitment tracker and proactively inform the Head of RA (Europe) and other involved business units regarding all identified risks related to the planned MA applications. You will also have the opportunity to take part in the training of regulatory personnel and liaise with other company departments.
As Regulatory Affairs Project Manager, you will be a service-oriented logical thinker with a positive, can-do attitude. An ability to work autonomously and possess problem-solving skills is essential. You will also possess good cultural awareness and sensitivity.
This position will be located outside Dublin city center.
Our client is a global specialty and branded pharmaceutical company, improving the health of patients across the world through their high quality and affordable medicines.
Main Duties and Responsibilities:
- Representing regulatory submission function in the projects related to the operational changes, technical projects or the projects driven by PV department.
- Compile country specific regulatory intelligence from Regulatory Affairs Managers responsible for regulatory submission activities in all EU CIS territories and provide the consolidated intel on the Regulatory Plan to the stakeholders from other departments.
- Provide support in respect to registration strategy (assist in development of regulatory strategy) as well as monitoring the impact of changing regulatory environment on submission strategies.
- Introduction of the new projects to regulatory submission team and communications of the project status to the local affiliates in scope of the project via regular meetings.
- Ensure documentation and submission deadline requirements are met, as well as tracking submission progress.
- Coordinate with Regulatory Compliance the preparation of responses to Request for Information (RFI) received from Health Authorities to achieve the harmonised registered data across the countries.
- Support / Coordinate the data needed to make all required registration fees in a timely manner.
- Ensure information exchange and periodic reporting to the Head of RA (Europe) – updating and maintaining regulatory submission and RFI tracker on a weekly basis.
- Provide regulatory input for the Annual PQR and PSUR / PBER.
- Generate KPI reports and compile updates for Quality Systems Management Review (QSMR) meetings.
· Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
· Minimum 3 years' experience in a regulatory affairs environment
· Relevant experience in, and general knowledge of, the pharmaceutical industry
· Knowledge of EU and other regions current registration and dossier requirements.
If you feel this description is something that fits your professional background and character, please apply now, or contact the team at Wentworth Life Sciences.