Regulatory Affairs Specialist

Sandoz; Almere; On-site; EUR 60,000 - 90,000; Full time

Job summary

Sandoz is seeking a Regulatory Affairs Specialist in the Netherlands to manage registrations, product information and artworks for existing and future products. You will combine meticulous attention to detail with strong planning skills while collaborating with internal and external stakeholders.

In this highly regulated environment you will maintain dossiers, coordinate translations, respond to health authorities and support product launches, site transfers and audits.

Qualifications

• Bachelor's or Master's degree in biomedical sciences, pharmacy, pharmacology or related field.
• Experience in the pharmaceutical industry, preferably in a highly regulated environment.
• Excellent command of Dutch and English, both written and spoken.

Responsibilities

• Maintain registration dossiers, prepare official product information and coordinate translations of documents including Patient Information Leaflets and SmPCs.
• Manage artworks for the product portfolio and ensure packaging texts comply with registered information and regulations.
• Respond to questions from local health authorities and support audits and inspections.
• Contribute to timely approval of registration applications and support product launches and site transfers.
• Provide Regulatory Affairs support to internal and external stakeholders and keep RA databases up to date.

Skills

Detail-Oriented

Effective Communication

Regulatory Affairs

Stakeholder Management

Education

Bachelor's or Master's degree in biomedical sciences/pharmacy/pharmacology or related field

Tools

Microsoft Office

Job description

Job Description Summary

At Sandoz, our Purpose is pioneering access for patients

Job Description

As a Regulatory Affairs Specialist at Sandoz, you will work on registrations, product information and artworks for existing and future products. You combine attention to detail with strong planning skills and collaborate with a range of internal and external stakeholders.

What will you do?

As a Regulatory Affairs Specialist, you ensure that our products and the related product information comply with applicable registration requirements.

Your Key Responsibilities:

• You maintain registration dossiers, prepare official product information and coordinate translations of documents including Patient Information Leaflets, Summaries of Product Characteristics (SmPCs) and packaging texts.
• You are responsible for managing artworks for our product portfolio. You coordinate changes from initiation through implementation and ensure that packaging materials comply with the registered product information, applicable laws and regulations, and internal quality standards.
• You respond to questions from local health authorities and support internal and external audits and inspections.
• You contribute to the earliest possible approval of registration applications and support product launches and manufacturing site transfers.
• You provide general and product-specific Regulatory Affairs support to internal and external stakeholders, including Business Units, Portfolio & Launch, Supply, manufacturing sites, international Artwork teams, Medical and Quality.
• You keep Regulatory Affairs databases up to date and ensure that relevant GxP and RA documentation is archived in accordance with applicable requirements.
• You support local RA projects and develop into a subject matter contact for specific RA processes, tools or projects.

In carrying out your responsibilities, you ensure compliance with Sandoz standards, local procedures, applicable laws and regulations, and health authority requirements. You work accurately, monitor relevant deadlines and maintain professional communication with internal and external stakeholders.

What you’ll bring to the role:

Essential Requirements:

You are detail-oriented and proactive, take ownership of your work and are comfortable working in a highly regulated environment. You can work independently while recognising when alignment with others is needed.

You also bring:

• a Bachelor’s or Master’s degree, preferably in biomedical sciences, pharmacy, pharmacology or a related field;
• Experience in the pharmaceutical industry, preferably in a highly regulated environment;
• Excellent command of Dutch and English, both written and spoken;
• Strong planning and organisational skills with attention to detail;
• Good written communication skills and experience with data management and IT systems, including Microsoft Office;
• Ability to set priorities independently, make informed decisions and deliver high-quality results;
• Ability to look beyond the immediate question or assignment, recognise connections and maintain an overview of the bigger picture.

You’ll receive:

• We offer temporary employment for 1 year with probation period with flexible working, learning and development opportunities.
• We offer indefinite employment contract based on performance after the first year of employment.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic humanrightof good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, wehave the opportunity toshape the future of Sandoz and help even more people 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 careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

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, Effective Communication, Regulatory Affairs, Stakeholder Management