Regulatory Affairs Senior Manager

TL;DR

Regulatory Affairs Senior Manager: Leads post-approval regulatory activities for hirify.global’s global legacy products with an accent on defining strategies, ensuring compliant submissions, and lifecycle maintenance. Focus on preparing variation packages, monitoring registration status, and coordinating with market companies, partners, and cross-functional teams in international markets, particularly EU.

Location: Sant Feliu de Llobregat, Spain

Company

Building the future of medical dermatology by addressing unmet patient needs, recognized as a Top Employer in Spain since 2008 and in Germany since 2025.

What you will do

• Define regulatory strategies, procedures, and timelines for product lifecycle maintenance in international markets, liaising with local RA managers, consultants, and partners.
• Prepare and review variation packages for labelling, administrative, clinical, and non-clinical changes, ensuring timely delivery to partners and health authorities.
• Follow up on regulatory procedures, update databases, and inform the organization for implementation of changes.
• Monitor product registration status, maintain schedules for renewals and variations.
• Lead regulatory activities through consultants, CROs, local agents, and partners; support budget preparation.
• Provide regulatory expertise in cross-functional projects and support market companies as needed.

Requirements

• Bachelor’s Degree in Life Sciences; advanced degree preferred.
• Minimum 8-10 years of experience in post-approval regulatory procedures, particularly in EU markets.
• Hands-on experience managing EU registration procedures (CP/DCP/MRP), dossier preparation, submission, and authority interactions.
• Fluent English.
• Strong ability to build relationships and collaborate in global teams across functions and scientific disciplines.

Culture & Benefits

• Environment that invests in people’s growth and career progression.
• Focus on independent thinking, ownership, and impactful contributions.
• Work with care, courage, simplicity, and innovation where it matters.