Senior Regulatory Affairs Executive

CZ04 (FCRS = CZ004) Sandoz s.r.o; Cork; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Pension scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Job summary

Sandoz in Ireland is seeking a regulatory affairs professional to manage new Marketing Authorisation applications and lifecycle activities. You will coordinate with internal and HPRA stakeholders to ensure timely submissions and compliance with EU and local requirements.

The role requires a strong regulatory background, experience with HPRA, and excellent English communication. A hybrid working arrangement, competitive salary, and development opportunities are offered.

Qualifications

• 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.

Responsibilities

• 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.
• Maintaining 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 CAPAs, change controls and deviations assigned to Regulatory Affairs.
• Timely gap assessment of Global Operating Procedures and update of local procedures where applicable.

Skills

Regulatory affairs

HPRA experience

Regulatory submissions

English proficiency

Communication skills

Education

BSc in chemistry/Life sciences

MPharm desirable

Job description

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

• 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 Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!