Global Regulatory Affairs Manager

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Mission

To coordinate regulatory activities triggering successful life-cycle management for Almirall Global products approved worldwide in liaison with local regulatory responsible at market companies, consultants, or partners and in close collaboration with CMC and roll-out regulatory responsible.

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

Why working with Almirall? We are a people-centric company where employees are at their best, patients and customer are at the heart of every decision, and our focus and agility allow us to deliver greater impact for all.

Additionally, for the 16th year in a row, we have been certified as Top Employer Spain!

This reaffirms our commitment to create a unique work environment that allows our employees to develop their skills to the fullest and grow both professionally and as individuals. We are thankful to have a great team that is proactive, innovative, and eager to transform the world of people with skin conditions. We are proud of each one of our employees, their development, and growth : they are the success of the company.

Our purpose

Transform the patients´ world by helping them realize their hopes & dreams for a healthy life".

Our values

Care : we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.

At Almirall, it’s all about people! #wearealmirall

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Research and Science

Pharmaceutical Manufacturing and Biotechnology Research

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