Job ID 310494BR
Position Title Regulatory Affairs Advisor
Job Description180. The Regulatory Affairs Advisor will provide regulatory support to deliver high impact on the development portfolio and assist to ensure excellence and compliance of the Irish portfolio with approximately 180 licences.
Your responsibilities include, but are not limited to:
- Preparation, QC and submission of national dossiers and licence maintenance applications to the local Health Authority (HPRA)
- Facilitate approval of new product licences, indications and dosage strengths for the Irish market.
- Support the regulatory activities relating to product launches; Maintain compliance of existing assigned Product Licences with European and national legislation
- Participate and support Global RA as a Euro sub-team member for applications filed under the EU systems, namely Mutual Recognition and Centralised procedures
- Maintain local RA databases and Global compliance tracking systems to record local licence information (new indications, changes in indications, changes in product specifications, changes in licensing, new products and progress with development of new products).
- Review and update all product labels and leaflets (artwork) for consistency with the licence for implementation according to required timelines.
- Foster good relations with the HPRA
- Assist in the review of promotional material for consistency with the licence
- Prepare and update Abbreviated Prescribing Information to be used in promotional material
Minimum requirementsWhat you’ll bring to the role:
- BSc/ Life Sciences Degree minimum
- Minimum of 3 to 4 years regulatory experience in the pharmaceutical industry
- Effective communication and negotiation skills.
- Fluency in English as a business language
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Novartis Ireland Ltd. has been certified as a Top Employer 2020 by the Top Employers Institute for its exceptional employee offerings!
#LI-NOV = Novartis
Division Global Drug Development
Business Unit REG AFFAIRS GDD
Company/Legal Entity Novartis Ireland Limited
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Shift Work No