Summary/ Mission
The Global Regulatory Affairs Senior Manager leads assigned post‑approval regulatory activities for Almirall's general legacy products.
The role defines regulatory strategies, and ensures timely and compliant submissions in coordination with market companies, partners, consultants, and cross‑functional teams. It ensures accurate product registration status, drives regulatory implementation across the organization, and represents Regulatory Affairs in internal and external meetings.
Tasks and Responsabilities
- 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.
- Leads 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 expertise and leadership in cross-functional projects aligned with business strategy definition.
Education
- Batchelor's Degree in Life Sciences. Advanced degree preferred but not required.
Experience and Specific Knowledge
- Minimum 8-10 years of experience
- Strong knowledge of post-approval regulatory procedures in the international markets, particularly in the EU markets. Familiarity with drug development and pre-approval procedures is a plus.
- Hands on operational experience of managing EU registration procedures (CP/DCP/MRP), dossier preparation and submission, and Regulatory authority interactions.
- Fluent English.
- Ability to build team relationships and collaborate in a global team environment with key stakeholders across the organization.
- Ability to effectively collaborate with various business functions as well as cooperate with some scientific disciplines.
Why work 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 17th year in a row, we have been certified as Top Employer Spain, and also Top Employer Germany for the first time.
This strengthens our commitment to create a unique work environment that helps our employees to develop their skills to fullest and grow both professionally and as individuals.
We are delighted 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.
- 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.
At Almirall, it's all about people
#wearealmirall