Regulatory Affairs Manager - Submissions Team

Are you a results and performance driven Regulatory Affairs professional with 4 to 5 years of experience in submissions looking to move the next big step in your career? Are you also a leader by nature, with strong attention to detail and positive and proactive approach to business looking to manage your own team? Look no further, here is the opportunity you have been dreaming about!

This is a one of a kind chance to work and grow within a well-established pharmaceutical company operating globally.

Their submission team is growing fast and they need someone like you who can join them and work within a fast-paced and international environment, manage the submissions process and achieve long term account goals in line with the company vision and values.

This is a permanent full-time position based in Dublin.

What will you do in this job?

• You will manage and oversee the coordination of regulatory submissions assigned to the RA submissions team
• You will ensure that the documentation compiled by your team is complete and complies with the regulatory requirements.
• You will be tracking the submission process by communicating efficiently with the relevant stakeholders and local service providers.
• You will ensure timely responses to regulatory agencies queries raised during the process.
• You will ensure that Marketing Authorisation Applications are current and compliant.
• You will ensure that Change Control requests are assessed and regulatory impact assessment is performed with respect to regulatory requirements.
• You will assist new business development through audit.

What do you need to be successful in this job?

• You have 4-5 years of submission experience, ideally with some management/supervisory experience.
• You have strong working knowledge of regulatory requirements and procedures required, with a solid understanding of EU regulations which includes a good understanding of eCTD requirements.
• You have a solid knowledge of IT tools specific for in RA and pharmaceutical sector (as eCTD, databases, change control management etc.)

What's in it for you?

• A competitive salary.
• A benefits package which includes pension and health care contribution, bonus, etc.
• Time to rest, with 23 days of paid annual leave.

And... much more!

The Next Step for you:

Interested in this role? Please send your CV to SIMONA MORELLI at Next Generation Recruitment by clicking on the Apply button!

Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there.

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