Manager, EU & International Regulatory Affairs, Global Rare Diseases

What we are looking for
Reporting to the Lead, EU & Int’l Regulatory Affairs, Global Rare Diseases, the Manager, EU & International Regulatory Affairs develop regulatory strategies for EU & International markets to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives.

You will be responsible for

In collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD products

In full alignment with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products.

Contribute to the preparation and/or review of submissions to relevant markets to ensure the high quality of the documentation

In agreement with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissions

Critically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission.

Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory Affairs

In full alignment with the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases, provide regulatory guidance to colleagues from other functional areas

Provide regulatory expertise in support of due diligence assessments

Represent the Regulatory Department at the Core Team as a global RA member, where needed

Support the Lead, EU & Int'l Regulatory Affairs, Global Rare Diseases in the preparation of the needed documents for the meetings and interactions with regional regulatory authorities

You will need to have

3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug development

Life Science Degrees

Flexible, collaborative, open minded

Well-developed written and oral communication and listening skills

Time management skills and demonstrated ability to manage complex assignments

Well-developed analytical and problem-solving skills

Ability to work independently and as part of a team

We would prefer for you to have
Experience in leadership and coaching is an asset.

Location
The role can be based in the HQ in Parma, Italy or in Dublin, Ireland.

Compensation Range (package applied for role based in Italy)
The minimum salary for this role is €46,800, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, and flexible benefits programme.

The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.

What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.

#J-18808-Ljbffr