Selection of Alert Frequency
Select how often (in days) to receive an alert :
Tasks and Responsibilities
* Define the strategy, regulatory procedures, and oversight of timelines and requirements for assigned product(s) in lifecycle maintenance for markets in the international region by liaising with Local RA (Regulatory Affairs) managers at Market Companies, local consultants or partners, and when applicable, with CMC and roll-out regulatory responsible.
* Prepare and/or review variation packages for labelling, administrative, clinical, and non-clinical changes for assigned product(s) lifecycle maintenance in international markets, ensuring timely delivery to partners, market companies, and health authorities.
* Follow up on regulatory procedures until final resolution, report all relevant information and documents to regulatory databases, and inform the organization according to internal procedures to implement regulatory changes.
* Monitor the registration status of responsible products and maintain an updated annual schedule of Renewals and Variations, including all regulatory procedures.
* Request implementation of regulatory changes affecting packaging materials and participate in their approval process.
* Supervise activities related to regulatory purposes carried out by consultants, CROs (Contract Research Organizations), local agents, and partners.
* Support the preparation and management of the Department's budget.
* Assist market companies in planning regulatory procedures as needed, especially during periods of increased or occasional regulatory support, and represent them in corporate projects.
* Provide regulatory support in cross-functional projects aligned with business strategy.
* Develop and maintain policies and procedures governing regulatory operations with market companies and partners.
* Assist in regulatory matters during meetings with other departments, external companies, or health authorities.
Education
Degree in Biology, Pharmacy, Medicine, or Chemistry.
External & Internal Stakeholders
1. 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, regulatory consultants, CROs, and local agents.
Values
* Care: We listen and empathize, value diverse perspectives and backgrounds, and support each other's success.
* Courage: We challenge the status quo, take ownership, and learn from our successes and failures.
* Innovation: We focus on the patient and customer, create novel solutions, and foster entrepreneurial mindsets.
* Simplicity: We act decisively, understand the reasons before acting, and aim for agility and simplicity.
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