Regulatory Affairs Lifecycle Process Specialist
Há 5 dias
Adalvo, a dynamic and fast-paced company based in Portugal, seeks an exceptional Regulatory Affairs Lifecycle Process Specialist to join its team. Job Summary
The successful candidate will be responsible for ensuring compliance with applicable laws, regulations, and guidelines to facilitate the approval of all post-approval activities of products.
About the Role
This role reports directly to the Director, Operational Regulatory Affairs and is located in Portugal. As a key member of the lifecycle management team, you will provide high-quality advice on regulatory issues to team members by maintaining awareness of current regulatory legislation, guidance, and practice related to post-approval activities.
You will assess technical complexities, scientific challenges, and regulatory landscapes with full accountability to end business requirements. Your decision-making skills will impact launches and replenishment orders, and you will proactively engage in all post-approval activities to ensure project deliverables are met and overcome regulatory enquiries.
Key Responsibilities:
- Provide expert regulatory advice to team members
- Assess technical complexities and scientific challenges
- Engage in post-approval activities to ensure project deliverables
- Coordinate variations, renewals, and MA transfers
- Compile and publish submissions using electronic publishing software
- Ensure stronger compliance on data and knowledge management
Requirements and Qualifications
To succeed in this role, you will need:
- Solid regulatory affairs expertise and technical background
- Excellent communication and planning skills
- Strong organizational skills and attention to detail
- Direct project management skills and ability to work independently
- English language: advanced level, both speaking and writing
- Computer skills: very good knowledge of MS Office tools
- Project management capabilities, including creation of timelines, organization of meetings, meeting minutes, planning, and execution
Estimated Salary Range: €55,000 - €65,000 per annum, depending on experience.
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