Regulatory Affairs Specialist - Settore Healthcare

Uriach Italy; Assago; On-site; EUR 30,000 - 45,000; Full time

Job summary

A leading nutraceutical company based in Italy is seeking a Regulatory Affairs Specialist to join their team. The ideal candidate will have experience in regulatory affairs within the healthcare sector, particularly in food supplements for Italy and Romania. Responsibilities include ensuring product compliance, supervising regulatory activities, and collaborating closely with various departments. Candidates must possess a Bachelor's degree in a scientific field and demonstrate strong communication and organizational skills. Available to travel, preferred domicile in Milan.

Qualifications

• 1-2 years experience in Regulatory Affairs in healthcare sector.
• Experience in food supplements in Italy and/or Romania.
• Excellent knowledge of the English language.

Responsibilities

• Ensure compliance of products with applicable legislations.
• Supervise regulatory activities for Italy and Romania.
• Direct interaction with Global regulatory.
• Control of claims in local and global formulations.
• Support for new projects in collaboration with R&D.

Skills

Regulatory Affairs experience

Product registration

Communication skills

Organizational skills

Knowledge of English

Interpersonal skills

Education

Bachelor's degree in scientific field

Job description

With more than 185 years of history and through business development in more than 70 countries, Uriach Italy is a leading company in the European nutraceutical market. Some of our iconic brands are Aquilea, Fisiocrem, Laborest, with a strong presence in major European markets.

Today Uriach has more than 1300 employees between subsidiaries in Spain, Italy, Portugal, Germany, Austria, France, Switzerland and Romania. We have a joint venture agreement to market our brands in Greece, and we continue to expand our activities through distribution contracts in more than 25 countries worldwide.

We believe that the power of nature, enhanced by science, is the most appropriate way to improve human health and well-being.

People are the essence of the company, and factors such as research, innovation, and quality are inspirational in creating new products with a sustainable slant.

We want to have a positive impact on both people's lives and the planet.

With a view to strengthening our Regulatory Affairs team, we are offering an opportunity as Regulatory Affairs Specialist for the Region Italy-Romania.

Be prepared to:

• Ensure compliance of products with applicable legislations (food supplements, cosmetics, medical devices). Control and adaptation to new regulations.
• Product registration activities.
• Supervision of regulatory activities for Italy and Romania.
• Direct confrontation with subcontractor regulator and regulatory consultants.
• Direct interaction within Global regulatory.
• Collaboration with foreign distributors in order to register Laborest products.
• Control of claims and allowed amounts of ingredients in local and global formulations, specially for food supplements
• Support for new projects in collaboration with R&D, Marketing and Project Management.
• Preparation of packaging texts with direct discussion with Marketing teams. And updating of packaging texts in use.
• Verification of communication of marketing materials.
• Review of texts on product and institutional websites.
• PIF validation of cosmetic products.
• Support in updating the Technical File of medical devices and communication with notified bodies and national authorities.
• Post-market surveillance activities in collaboration with Quality and pharmacovigilance.

For this role we require:

• Experience of at least 1-2 years in Regulatory Affairs department in healthcare sector.
• Experience in food supplements in Italy and/or Romania.
• Bachelor's degree in scientific field.
• International experience will be considered a plus.
• Results-oriented approach in a fast-paced environment.
• Proven organizational, interpersonal and communication skills at different levels.
• An excellent knowledge of the English language.
• Available to travel.

Preferred domicile: Milan

Uriach Italy Srl is an equal opportunity company. In recruiting, our choices are based on experience, skills, passions and ambitions. We firmly believe that diversity adds incredible value to our teams, our products and our culture. Through it we can find the best ideas and solutions and have a positive impact on both people's lives and the planet.