Job Description
Our Client is recruiting for a Regulatory Affairs Manager newly created management position will be in Dublin. New to Ireland this pharmaceutical company specialised in the development and worldwide marketing of innovative drugs and food supplements for the well-being of men and women throughout their lives.
Job Spec
Implement strategic regulatory plans for preclinical and clinical programs.
Ensure compliance with applicable regulations and guidelines related to preclinical and clinical, regulatory submissions, product launch, labelling, and promotional activities.
Contribute to successful regulatory activities pertaining to Health Authority meetings and negotiations.
Work closely with development teams.
Work to ensure most efficient processes are implemented and followed.
Review responses to inquiries from regulatory agencies.
Ensure the most efficient regulatory filings.
Contribute to successful US, EU and rest-of-world regulatory filings and post-approval regulatory activities.
Person Spec:
Experience in the pharmaceutical industry with at least 3 years regulatory affairs management experience in regulatory operations.
A demonstrable track record of success working in a global matrix organisation, capable of managing autonomously, of setting the priorities.
Self-motivated, flexible and creative leader, able to prioritise, multi-task and work in a fast-paced and demanding environment.
Decisive and proactive with hands-on, can-do style and attitude and the ability to prioritise are critical for success.
Excellent writing, communication, presentation, skills.
Demonstrated project management skills.
Strong interpersonal and negotiation skills.
Strong understanding of international pharmaceutical guidelines and regulations.
A proven ability to work under pressure and adhere to deadlines.
For further information on this Regulatory Affairs Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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