Regulatory Affairs Specialist

NL23 (FCRS = NL023) Sandoz B.V; Almere; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Sandoz B.V. is seeking a Regulatory Affairs Specialist to manage registrations, product information, and artworks for current and future products.

You will combine meticulous attention to detail with strong planning and collaborate with a wide range of internal and external stakeholders. You will ensure compliance with registration requirements, coordinate document translations, and support audits, inspections, and regulatory submissions across the product lifecycle.

Qualifikationen

• Detail-oriented and proactive in a highly regulated environment.
• Ability to work independently and align with others when needed.
• Experience in pharmaceutical regulatory affairs preferred.

Aufgaben

• Maintain registration dossiers and coordinate translations of documents including PI and SmPCs.
• Manage product artworks and ensure packaging texts comply with registered information.
• Respond to health authority questions and support audits/inspections.
• Support product launches and site transfers, and provide RA support to internal/external stakeholders.

Kenntnisse

Regulatory Affairs

Stakeholder Management

Attention to detail

Planning

Ausbildung

Biomedical sciences / Pharmacy / Pharmacology

Tools

Microsoft Office

Jobbeschreibung

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 human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape 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

Our Purpose

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!