Senior Regulatory Affairs Specialist

Job title:

Senior Regulatory Affairs Specialist

Company

Aspen Pharmacare

Job description

DescriptionThe Senior Regulatory Affairs Specialist is responsible for managing regulatory activities for assigned countries, ensuring compliance with local regulations and timely product registration. This includes handling submissions, maintaining marketing authorizations, addressing health authority queries, and ensuring registration dossiers meet standards. The role involves strategic regulatory input, liaising with internal and external stakeholders, and monitoring the impact of regulatory changes on submissions and product lifecycle.Key Responsibilities:

• Regulatory Submissions & Compliance: Prepare and manage registration dossiers, maintain marketing authorizations, and respond to health authority queries.
• Stakeholder Communication: Provide updates to internal teams and liaise with health authorities and service providers.
• Strategic Support: Contribute to regulatory strategy and assess the impact of changing regulations.
• Lifecycle Management: Manage variations, renewals, and regulatory changes for assigned products.
• Promotions and Marketing: Ensure compliance of promotional material with national regulations.
• Quality & Documentation: Oversee labelling, maintain accurate records, and support audits and inspections

The role requires a high level of integrity, adaptability, and a solutions-driven mindset, with the ability to work autonomously and within a matrix team environment.RequirementsRequirements:

• Education: Degree in Life Sciences (BSc, MSc, PhD, or Pharmacist).
• Experience: 3–5 years in regulatory roles within the pharmaceutical industry.
• Skills: Results-oriented, proactive, strong communication and multitasking abilities, and cultural awareness.
• Languages: Fluent in Dutch, French, and strong English skills.
• Location: Office is based in Zaventem, Belgium (Hybrid working)

Work LevelMid-LevelTypePermanentSalaryMarket RelatedEE PositionNoLocationBelgium

Expected salary

Location

België

Job date

Wed, 27 Nov 2024 04:52:43 GMT

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