Regulatory Affairs Coord

Overview:
Responsible of handling regulatory activities required to submit, approve and launch new products and the maintenance of marketed goods from the assigned brands. Moderate to high complexity projects.

Regulatory contact point of the company of Regulatory Health Authorities

**Responsibilities**:

- To stay updated on changes in local, and when applicable EU legislation regulations, and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.
- To execute local regulatory activities to assure new products meet submission and approval timings to comply with commercial launch goals.
- Registration submission and follow up with Health Authorities, until product approval and launch. to ensure that the requirements of legislation and Health Authorities are met in relation to the company's products.
- Preparation of dossiers for national registration.
- Local notification in Spain of food supplements, cosmetics and hygiene products.
- Management of national phases with AEMPS, of European procedures (DCP, CP) to obtain marketing authorization.
- Preparing and submitting variations and revalidations within the established deadlines
- Coordination and preparation of Answers to deficiencies letters received from Health Authorities.
- Maintains regulatory files/database/Archives and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies.
- Ensure compliance with the regulations in product labeling; following the procedures described in the company’s SOPs.
- Maintain regulatory files and data systems in compliance with SOPs.
- Represent local Regulatory Affairs from Spain in project meetings.
- Collaborate with Technical
- PhV reviewing product labelling changes for compliance with company’s SOPs.
- Collaborate to define the best strategies and ways for efficient product registrations and launches in Spain.
- Maintain a high level of regulatory knowledge, considering current or regulations pending to be approved.
- Support to Quality and Pharmacovigilance Departments, in some routine tasks

Qualifications:

- Education: Degree in Pharmacy (preferred), Chemistry or Biology. Master is a plus.
- Languages: Fluent Spanish and English (intermediate/high level)
- Experience (years/area): 5-8 years of experience in the same functions.
- Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, including GMP, and registration dossier CTD format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.). Knowledge in Pharmacovigilance and GDPs is a plus.
- Travels: Occasionally