Sr. Specialist Regulatory Affairs
Baxter International
San Ġwann, Malta
Essential Duties and Responsibilities
- Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals;
- Interact with non-regulatory support groups (i.e., manufacturing, product stability, quality, clinical, etc.) to request documentation necessary to support product renewals;
- Track status and progress of regulatory documentation that will be used for renewals;
- Coordinate and compile responses to regulatory authority renewal questions (under supervision);
- Use an electronic document management system to compile documents to support product renewals for submission to Health Authorities;
- Answer internal queries for assigned products;
- Maintain Database of Regulatory Requirements for renewals.
Qualifications
- Knowledge of regulations. Medical Device registration/renewal experience preferred;
- Scientific knowledge;
- Administrative and project management skills;
- Ability to contribute to multiple projects from a regulatory affairs perspective;
- Ability to multitask and prioritize;
- Interpersonal and communication skills;
- Technical system skills (e.g. word processing, excel, SmartSheet, databases, online research);
- Proofreading and editing skills;
- Ability to independently identify compliance risks and resolve or escalate as necessary.
Education and/or Experience
- Regulatory experience within a healthcare environment;
- Bachelor’s degree or country equivalent in a relevant scientific discipline;
- Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification.
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