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Jefferson Wells
Jefferson Wells

Regulatory Affairs Specialist

Published on Jobat.be 19 days ago

Regulatory Affairs Specialist

Our partners innovate to bring treatments to their patients that significantly improve their lives.?Together with the government and other health partners they are working towards qualitative, affordable and accessible healthcare.

Job description

The primary responsibility of the Regulatory Affairs Specialist is to support the post-approval CMC regulatory activities related to small molecules in all global markets. Support teams, including representing CMCRA in meetings, as needed and provide direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements, define regulatory strategy, write CMC variation dossiers and coordinate responses to Health Authorities (HA). Additional responsibilities might include renewal variations (as requested), development of product-specific regulatory strategy documents; technical review and approval reports and other source documents; change controls and other related duties as assigned.

Profile

• At least a bachelor degree (scientific orientated)
• Direct and significant CMC regulatory experience with post approval amendments and variation dossiers for small molecules worldwide
• Strong knowledge of global/worldwide regulatory guidelines and regulations is required
• Experience in supporting Health Authority meetings (FDA & APAC is a plus, EMA is a must) preferred
• Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
• Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to motivate people within a matrix team environment as an individual contributor, decision maker, and leader
• Excellent knowledge of English (written & spoken)
• Remote work possible, max once a month on site

Offer

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?

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    9 days left to apply

    Characteristics

    Requirements

    • Professional bachelor (Higher Education Short Type)
    • English

    Offer

    • Full-time
    • Group insurance
    • Company car
    • Family hospital insurance

    Apply before

    • 7 October

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