Junior Regulatory Affairs Officer

• Location: Dublin, Ireland

About the job

As a Junior Regulatory Affairs Officer you will be responsible and involved in the co-ordination, preparartion, submission and follow up of registration applications to the Irish and or UK regulatory authorities. These activities should be actioned expeditiously and to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals. In addition you may also be required to support the launch of new products.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Prepare efficiently and submit responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
• For Centralised Applications, ensure that Global Business Units are informed of status of applications and artwork is developed to support new submissions and product launches.
• Ensure Global Business Units are kept informed of status of submissions to national regulatory authorities, including approvals and withdrawals.
• Participate and support in the preparation of high-quality regulatory submissions to the authorities within the agreed timelines.
• Prepare and submit, according to agreed timelines, post-licencing regulatory submissions, including variations, renewals and Article 61(3)s via national, mutual recognition, decentralised procedures in order to maintain and update existing marketing authorisations, under supervision, to ensure continued development of existing products.
• Prepare, review and maintain labelling, package leaflets and summary of product characteristics as applicable for national, mutual recognition, decentralised and centralised licences within portfolio to ensure compliance with current legislation and registered particulars and take action, as agreed with supervisor, to secure regulatory approval and support new submissions and product launches as required.
• Support activities to ensure regulatory compliance, identifying, highlighting and resolving issues where necessary.
• Participate in the preparation of high-quality regulatory submissions to the authorities within the agreed timelines.
• Prepare efficiently and submit responses to enquiries received by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
• For Centralised Applications, ensure that Global Business Units are informed of status of applications and artwork is developed to support new submissions and product launches.
• Ensure all relevant stakeholders are kept informed of status of submissions to national regulatory authorities, including approvals and withdrawals.

About you

• Life sciences or chemistry degree or equivalent professional qualification.
• Experience in the pharmaceutical industry desirable, not essential.
• Administratively well organised, demonstrating attention to detail, strong written and oral communication skills. Able to communicate effectively and efficiently with other functional departments in the business with the support from management.
• Knowledge of basic regulatory requirements (though training provided both on the job and externally).

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Pursue Progress . Discover Extraordinary .

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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