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Tasks and Responsibilities
* Define the strategy, regulatory procedures, and oversee timelines and requirements for assigned product(s) in lifecycle maintenance for markets in the international region, 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, ensuring timely delivery to partners, market companies, and health authorities.
* Follow up on regulatory procedures until final resolution, report relevant information and documents to regulatory databases, and inform the organization to ensure implementation of regulatory changes.
* Monitor the registration status of responsible products and maintain an updated schedule of Renewals and Variations, including all regulatory procedures.
* Request the implementation of regulatory changes affecting packaging materials and participate in their approval process.
* Supervise activities related to regulatory purposes carried out by consultants, CROs, local agents, and partners.
* Support the preparation and management of the Department's budget.
* Assist market companies with regulatory planning and support, especially when additional or occasional regulatory support is needed, and represent them in corporate projects.
* Provide regulatory support in cross-functional projects aligned with business strategies.
* 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
* 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.
o External contacts: Health authorities, Partners, Regulatory Consultants, CROs, and local agents.
Values
o Care: We listen, empathize, value diverse perspectives and backgrounds, and support each other's success.
o Courage: We challenge the status quo, take ownership, and learn from successes and failures.
o Innovation: We prioritize the patient and customer, create novel solutions, and empower entrepreneurial mindsets.
o Simplicity: We act decisively, avoid over-analysis, understand why before acting, and remain agile and straightforward.
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