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Tasks and Responsibilities
* Define the strategy, regulatory procedure and oversight of timelines and requirements for assigned product(s) in lifecycle maintenance for markets in the international region through liaison with Local RA (Regulatory Affairs) managers at Market Companies, Local consultants or partners and when applicable also with CMC and roll-out regulatory responsible.
* Prepare and/or review of variation packages for labelling, administrative, clinical and non-clinical changes for assigned product(s) lifecycle maintenance for markets in the international region ensuring they are delivered to partners, market companies and health authorities within the established deadlines.
* Follow up regulatory procedures up to final resolution, reporting on the regulatory databases all relevant information and associated documents. Also, inform the organization as per internal procedures to ensure implementation of regulatory changes.
* Monitor the registration status of products under responsibility and keep annual schedule of Renewals and Variations updated with all regulatory procedures to be performed.
* Request the implementation of the regulatory changes that affect the packaging materials and participate in their approval.
* Supervise activities carried out for regulatory purposes through consultants, CROs (Contract Research Organizations), local agents and partners.
* Supports in the preparation and integration of the Department’s budget.
* Support to market companies for products that may need it, for planning regulatory procedures, when there is a lack or extra need for occasional regulatory support and representing them in corporate projects.
* Provide regulatory support in cross-functional projects aligned with business strategy definition.
* Draw up and maintain the policies and procedures that govern regulatory operations with market companies and partners.
* Support in regulatory matters in meetings with order departments of the company, external companies, or health authorities.
Education
Degree in Biology, Pharmacy, Medicine or Chemistry.
External & Internal stakeholders
* Internal:
R&D Departments, Industrial Operations (IFA SA, Almirall Hermal, Ranke, External sites, Project Management, POP, Procurement), Quality Assurance, HQ (Alliance & Partners, Legal), Market companies.
* External contacts:
Health authorities, Partners, Consultants regulatory, CROs and local agents.
Values
• Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
• Courage; we challenge the status quo, we take full ownership and we learn from our success & failures.
• Innovation; we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
• Simplicity; we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
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