Pharmaceutical Affairs Professional
1 day ago
Grifols, S.A. is seeking an experienced Regulatory Affairs and Quality Specialist to join our team.
Key Responsibilities:Duties include:
- Coordinating with the Scientific Office Manager to secure approvals for product registration and variations.
- Following up on submissions to resolve regulatory issues efficiently.
- Responding to regulatory and technical queries from competent authorities.
- Addressing deficiencies or observations raised by regulatory bodies.
- Maintaining awareness of regulatory updates and ensuring compliance with new legislation.
- Managing regulatory correspondence between Grifols and competent authorities.
- Ensuring product artwork and promotional materials comply with regulations.
- Liaising with the local Qualified Person for Pharmacovigilance to support safety reporting and compliance.
- Supporting the renewal of office licenses and ensuring scientific office requirements are met.
Candidates must have:
- A Bachelor's degree in Pharmaceutical Sciences.
- 2–4 years of experience in Regulatory Affairs or a related field.
- Strong knowledge of regulatory requirements and compliance.
- Excellent communication and stakeholder management skills.
- Ability to work in a fast-paced, international environment.
- Detail-oriented with strong problem-solving abilities.
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