Pharma Regulatory Affairs Specialist - Flexible & Growth

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

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.