Junior Regulatory Affairs Officer

at  Sanofi US

Dublin, County Dublin, Ireland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate23 Jan, 2025Not Specified23 Oct, 2024N/AGood communication skillsNoNo
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Description:

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.

REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Dublin, County Dublin, Ireland