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Senior Regulatory Affairs Professional
3 semanas atrás
We are dedicated to bringing life-changing medicines to patients faster, without compromising on excellence and integrity.
Key Responsibilities:- Ensure efficient documentation management and record retention in compliance with regulatory requirements.
- Maintain knowledge of product information and collaborate with local, regional, and divisional customers.
- Contribute to project completion, manage time effectively, and develop plans for work activities within a team.
- Provide guidance on technical aspects of tender documents and analyze reports to improve operations.
- Review submissions for new product registration, line extensions, post-approval changes, and license renewals to ensure compliance with local regulatory requirements.
- Bachelor's Degree
- 3+ years of experience in Regulatory Affairs or a related function within the pharmaceutical sector
- Proven ability to oversee quality control support for others' work
- Knowledge of national and clinical trials legislation, and guidelines
- Ability to interpret and relay technical information with accuracy and attention to detail
- Opportunity to contribute to the development of life-changing medicines
- Chance to work with a talented team of professionals
- Experience in a dynamic and fast-paced environment
- Development opportunities to enhance your skills and knowledge