Back to search

Regulatory Affairs Senior Manager

Barcelona Region, Catalonia Permanent View Job Description
Regulatory Affairs is expected to play an increasingly strategic role, supporting product development, international registrations, business development activities and long-term portfolio strategy. The organization is seeking a senior Regulatory Affairs professional to play a key role in the future development of the Regulatory function, supporting international expansion, portfolio growth and strategic business initiatives.
  • 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 / ResponsibilitiesRegulatory 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.
Contact
Maria Cerezo
Quote job ref
JN-102026-7123147

Job summary

Function
Policy, Economics & Regulatory Affairs
Subsector
Policy, Economics & Regulatory Affairs Subsector
Industry
Life Sciences
Location
Barcelona Region
Contract type
Permanent
Consultant name
Maria Cerezo
Job reference
JN-102026-7123147
Maria Cerezo profile photo
Page Executive
María Cerezo LinkedIn
Associate Partner

Based in Spain, María has over 15 years of experience and recruits for executive, leadership and direction roles, in Life Sciences, Healthcare, Biotechnology, Pharmaceuticals, and Medical sectors.

Read more about María Cerezo

About Page Executive

Page Executive are inclusive Recruiters and Hirers, as reflected in our Clear Assured Platinum Standard Accreditation from the Clear Company. We are passionate about attracting diverse talent and are committed to ensuring our processes are inclusive and supportive.