Senior Regulatory Affairs Executive

Sandoz; Cork; Hybride; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Résumé du poste

Sandoz Ireland is seeking an experienced Regulatory Affairs professional to lead the preparation and submission of Marketing Authorisation dossiers and manage lifecycle activities for a portfolio of products. You will work with internal EU and local stakeholders to ensure compliance with HPRA and EU requirements, and respond to queries while monitoring regulatory changes.

The role requires a BSc in a relevant field with strong English communication skills and a track record in regulatory

Qualifications

• Bachelor-level science degree in a relevant field (Chemistry/Life Sciences) required or higher.
• Excellent written and verbal English communication skills.
• Excellent regulatory knowledge of Centralised, MRP/DCP/RUP, and IE National licensing procedures.
• Proven track record with HPRA inspections or interactions.

Responsabilités

• Prepare and submit new Marketing Authorisation applications and maintain lifecycle management for a portfolio of products.
• Collaborate with internal EU and Local stakeholders and other functions to meet objectives.
• Manage submission variations, renewals and MA transfers timely.
• Register Risk Management Plans and related materials with HPRA; ensure commitments are met.
• Respond to HPRA queries and liaise with departments and external sources for timely responses.
• Monitor regulatory changes and disseminate requirements to stakeholders in line with EU/HPRA.

Connaissances

Detail-Oriented

Regulatory Affairs

Formation

BSc (Hons) chemistry or life sciences

MPharm (Pharmacy) desirable

Description du poste

Job Description Summary

Join us, the future is ours to shape!

Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The purpose of the role is:

• Timely and accurate preparation and submission of registration dossiers to obtain and launch new Ireland Marketing Authorisations in collaboration with internal EU and Local stakeholders.
• Lifecycle maintenance of existing Marketing Authorisations in collaboration with internal, EU and Local stakeholders.
• Continued compliance with all relevant legislation, guidelines and practices, including EU, HPRA, Sandoz global and local requirements.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Responsible for new MA applications and lifecycle management of a portfolio of products authorised via Centralised, MRP/DCP/RUP, and Irish National procedures.
• Effective team working with other business functions to achieve company objectives.
• Oversight of preparation and timely submission of new Marketing Authorisation applications, variations, renewals, and MA Transfers.
• Registration of Risk Management Plans and associated educational materials with the HPRA, with cross functional working to ensure all commitments are met and implementation is appropriately recorded.
• Responding to application or licensing queries raised by the HPRA. Liaising with relevant company departments and external sources to ensure full and rapid responses.
• Maining oversight of regulatory changes and dissemination of implementation requirements to internal and external stakeholders in accordance with EU and HPRA requirements.
• Ensuring payment of HPRA fees within the departmental budget.
• Acting as a regulatory subject matter expert as required in internal audits and Health Authority inspections.
• Ensuring timely close out of Corrective and Preventative Actions (CAPAs), change controls and deviations assigned to Regulatory Affairs.
• Timely gap assessment of Global Operating Procedures and update of local procedures where applicable.

What you’ll bring to the role

Essential Requirements:

• BSc (Hons) chemistry or life sciences (upper second class or higher) required. MPharm (Pharmacy) highly desirable.
• Excellent written and verbal skills in English
• Excellent current regulatory knowledge of Centralised, MRP/DCP/RUP, and IE National licencing procedures.
• Proven track record of working with the HPRA.
• Strong communication skills.
• Proven track record in the delivery of regulatory, technical and scientific projects.
• Experience with internal/external inspections desirable.

You’ll receive

Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired

Detail-Oriented, Regulatory Affairs