Regulatory Affairs Officer
As a Regulatory Affairs Officer, you will obtain, manage, and maintain product Marketing Authorisations in line with business goals and legal requirements. You will be responsible for conducting associated Regulatory activities for the specified markets under the guidance and supervision of line management, contributing to project implementation and leadership.
We are an innovative global healthcare company dedicated to improving people's lives through science. We offer opportunities for career growth, networking, and personal development. Ready to get started?
Main responsibilities:
1. Coordinate, prepare, submit, and follow up registration applications to the UK and/or Irish Regulatory Authorities, ensuring high standards and timely approvals.
2. Assist in the preparation, distribution, and follow-up of registration documentation required for UK and Ireland.
3. Ensure all data supplied to Regulatory Authorities are of the highest quality in content and presentation, meeting deadlines.
4. Collaborate proactively with Global Business Units and other functions to meet project needs within timelines.
5. Support management in developing registration strategies and operating plans for product commercialization, locally and globally.
6. Contribute to the effective functioning of departmental and cross-functional project teams.
7. Support activities to obtain, manage, and maintain product Marketing Authorisations, contributing to project implementation.
8. Provide regulatory input to strategic and operational planning processes, supporting career growth and development.
9. Participate in a comprehensive rewards package and health and wellbeing programs, including parental leave.
10. We are a Disability Confident Employer committed to inclusive hiring and accommodations for candidates with disabilities.
Minimum requirements:
* Proven Regulatory Affairs experience in the pharmaceutical industry.
* Degree in life sciences, chemistry, or equivalent professional qualification.
* Familiarity with pharmaceutical R&D processes and scientific integration.
* Ability to work across therapeutic areas and represent Regulatory at meetings.
* Knowledge of EU Regulatory procedures and lifecycle maintenance for pharmaceuticals.
* Understanding of reporting procedures for health authorities and GMP requirements.
* Strong organizational, communication, and documentation skills.
Progress and innovation are driven by diverse teams committed to making miracles happen. Join us in pursuing progress and discovering the extraordinary together.
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