Regulatory Affairs Senior Manager

Page Executive; Barcelona; On-site; EUR 90,000 - 120,000; Full time

Job summary

Page Executive is seeking a senior Regulatory Affairs professional to shape strategic regulatory initiatives for an expanding pharmaceutical portfolio. You will lead international registrations and lifecycle management, coordinating with R&D, Quality, Medical Affairs, and commercial teams to drive timelines and compliance.

The role offers the opportunity to influence regulatory strategy in a transforming, globally active company with a broad Rx/OTC footprint across multiple markets.

Qualifications

• 8–15 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Proven track record managing international registrations and lifecycle activities.
• Experience developing and implementing regulatory strategies for development and marketed products.
• Experience coordinating activities across international markets with external partners.

Responsibilities

• Define and execute regulatory strategies for development and marketed products across global markets.
• Lead planning and execution of registrations, variations, renewals and lifecycle management.
• Monitor regulatory timelines, risks and deliverables across projects.

Skills

Regulatory strategy

Stakeholder management

Cross-functional leadership

International regulatory coordination

Project management

English fluency

Job description

• Opportunity to play a key role in shaping the future of Regulatory Affairs.
• Company undergoing a significant transformation

About Our Client

Our client is a well-established pharmaceutical company with an international footprint and a growing focus on innovation, portfolio expansion and global development. The company is investing in new capabilities, strengthening its international presence and enhancing cross-functional collaboration to support the next stage of its growth.The company manages an extensive portfolio across both prescription (Rx) and over-the-counter (OTC)

Job Description

Role / Responsibilities

Regulatory Strategy & Compliance

• Define and execute regulatory strategies for products under development and commercialized products across international markets.
• Lead the planning and execution of regulatory activities including new registrations, variations, renewals and lifecycle management.
• Assess and anticipate the impact of evolving regulatory requirements on the company's portfolio.
• Ensure compliance with applicable regulatory requirements across assigned markets.
• Contribute to regulatory decision-making related to product development, lifecycle management and portfolio initiatives.

Portfolio Management & International Regulatory Activities

• Coordinate regulatory activities across multiple international markets.
• Lead registration projects and maintenance activities for marketing authorizations worldwide.
• Support international product launches, market expansions and product transfer initiatives.
• Collaborate with distributors, partners and external consultants to ensure successful execution of regulatory plans.
• Monitor regulatory timelines, risks and key deliverables across assigned projects.

Business Development & Strategic Projects

• Participate in regulatory due diligence activities related to licensing, acquisitions and partnership opportunities.
• Assess regulatory risks and opportunities associated with new products and portfolio expansion initiatives.
• Support licensing-in and licensing-out projects from a regulatory perspective.
• Provide regulatory input into strategic business decisions and innovation initiatives.

Cross-Functional Collaboration & Leadership

• Act as a trusted regulatory partner to R&D, Quality, Medical Affairs, Operations, Supply Chain and Commercial teams.
• Lead and contribute to cross-functional projects involving multiple stakeholders.
• Drive continuous improvement initiatives aimed at enhancing regulatory processes and efficiency.
• Support the ongoing evolution of the Regulatory Affairs function and contribute to building future organizational capabilities.

The Successful Applicant

Profile / Experience

• 8-15 years of experience within Regulatory Affairs in the pharmaceutical industry.
• Solid experience managing international registrations and lifecycle management activities.
• Proven track record developing and implementing regulatory strategies for products in development and commercialized products.
• Experience working across international markets and coordinating activities with external partners and distributors.
• Exposure to licensing activities, regulatory due diligence, portfolio management and/or product transfer projects is highly desirable.
• Experience within corporate or headquarters environments will be particularly valued.
• Strong stakeholder management and influencing capabilities.
• Strategic mindset combined with a hands-on approach.
• Ability to thrive in dynamic and evolving environments.
• Fluent English.

What’s on Offer

• Opportunity to join a company undergoing a significant transformation and international growth journey.
• Exposure to a broad and diverse portfolio across both Rx and OTC products, marketed in more than 50 international territories.
• A highly visible role with significant interaction across R&D, Medical Affairs, Quality, Commercial and senior leadership teams.
• Participation in international projects, portfolio expansion initiatives and strategic business activities.
• The opportunity to make a tangible impact on the future evolution of the Regulatory Affairs function.
• A dynamic environment that encourages collaboration, innovation and professional growth.