Regulatory Affairs Professional EMEA

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A regulatory affairs professional who can support the

regional regulatory strategy for products in the oncology pipeline, preferably with experience of

clinical trial applications, scientific advice procedures, paediatric investigational plans or EU

marketing authorisation applications and variations.

Department: Global Regulatory Affairs

Reports to: EMEA Regulatory Liaison or EMEA Regional Therapeutic Area Leader

Your responsibilities:

• Input in development, post-approval and Life cycle management
• Participate in global regulatory team meetings as appropriate
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Have an understanding of the regional regulatory environment, and able to develop understand competitor intelligence and therapeutic area
• Liaison with Regulatory Agencies and Local Operating Companies
• Act as back-up for contact with Regulatory Agencies as needed
• Draft cover letters for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Liaise with LOCs, track and respond to queries in a timely manner
• Input in document and process development
• Assist in development of processes related to regulatory submissions
• Draft and review some document content (depending on level of regulatory knowledge /expertise)
• Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed
• Track dates of submissions and Regulatory Agency responses
• Clinical Trial Applications (CTA)
• Review protocols and ensure alignment with regulatory requirements
• Advise team on required documents and submission strategies in preparation of CTAs
• Ensure CTA submission packages are complete and available according to agreed timelines
• Review and approve clinical trial supply plans
• Marketing Authorization Applications (MAA)
• Provide regulatory support throughout registration process
• Provide regulatory support throughout life-cycle management
• Advise team on required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
• Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
• Assist with submission and acceptance of MAA
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans

Experience and education:

• University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
• Experience in regulatory affairs
• Teamwork experience
• Project management skills
• Oral & written communication skills in English
• Organization & multi-tasking skills
• Knowledge of the regulatory environment, guidelines and practice of EMEA regions

Our offer:

In response to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting extras such as:

• Meal vouchers of €7
• Net representation expenses of €80
• Hospitalization insurance
• Car + unlimited fuel card OR kilometer compensation
• 32 vacations
• End of year bonus
• Pension plan
• ECO vouchers
• Training opportunities

Diversity, Equality & Inclusion:

For over 130 years, diversity, equality & inclusion have been part of the cultural fabric and woven into how they do business every day. Their commitment to respect the dignity and diversity of all is embedded in their Credo.

They know that the success of their business depends on the best talent in a workforce that reflects the diverse markets they serve globally and an inclusive culture that values different perspectives and life experiences.

That’s why in Belgium we work to create an inclusive environment where different backgrounds, perspectives and experiences are valued and each of our people feels they belong and can reach their potential. Whoever they are. Diversity, Equity & Inclusion means "You Belong."