Regulatory Affairs Specialist

Job title:

Regulatory Affairs Specialist

Company:

Randstad

Job description

Currently, for our client, an international company from the pharmaceutical industry, we are looking for a person to join the international Regulatory Affairs Team.Regulatory Affairs Specialist Nr ref.: 328/9/2024/AM/256833/jobs.pl Warszawa (mazowieckie)What we offer

• employment contract for 12 months
• hybrid work (2 days a week remote work)
• benefits package: medical care, multisport card, life insurance
• work in an international environment

Your tasks

• regulatory Affairs data entry activities
• track incoming data entry requests and follow up until completion in alignment with global and regional data quality standards and procedures
• enter data in the relevant systems based on information provided by data owners
• scrutinize provided data with data owners and instruct data owners as needed, to ensure consistency and quality of data in the relevant systems
• ensure data owner alignment with data entered in the relevant systesms on their behalf
• support data owners with guidance, training, instructions on the process and requirements for maintaining data in the relevant systems
• provide ad hoc reports and data upon request, e.g. in relation to audits, inspections, quality investigations
• coordinate and/or perform other data management acitivites upon request
• contribute to process development and process improvement activities in EMEA and globally as needed

What we expect

• experience in a similar position in the pharmaceutical or cosmetics industry
• higher education
• Fluent knowledge of English and Polish (level C1/C2)
• good understanding of pharmaceutical Marketing Authorisation data and regulatory procedures (national as well as EU procedures)
• understanding of regulatory data planning and tracking requirements
• knowledge of compliance requirements and advanced process thinking
• proven ability to monitor multiple actions and timelines and follow up until timely completion
• ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level

Employment agency entry number 47this job offer is intended for people over 18 years of age

Expected salary

Location

Warszawa, mazowieckie

Job date

Thu, 24 Oct 2024 22:33:07 GMT

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