Regulatory Affairs Director

Henlius USA Inc.; España; On-site; EUR 120,000 - 180,000; Full time

Job summary

Henlius USA Inc. is seeking an experienced Regulatory Strategy and Project Management leader to serve as the primary interface with EMA and EU authorities.

The role develops EU regulatory strategies, leads market authorization and lifecycle activities, and ensures high-quality regulatory submissions across programs. You will oversee budgets, coordinate cross-functional teams, and drive continuous improvement in submission quality and processes.

Qualifications

• Master’s degree or above in Pharmacy, Medicine, Biology, or related life science.
• At least 10 years of relevant Regulatory Affairs experience in pharmaceutical/biotechnology industry.
• Strong knowledge of EU pharmaceutical regulations, registration pathways, and technical guidelines (EMA and MS requirements).
• Thorough understanding of end-to-end drug registration process and experience with regulatory submissions.

Responsibilities

• Serve as the primary regulatory and scientific point of contact with EMA, national authorities, internal stakeholders, customers, consultants, and vendors.
• Develop and implement EU regulatory strategies and action plans aligned with R&D and business objectives.
• Lead EU registration activities for products, including pre-marketing authorization and lifecycle management.
• Oversee progress, quality, and delivery of EU regulatory projects; identify challenges and drive resolutions.
• Provide regulatory input to product development, commercialization, partnerships, and business development.
• Lead preparation, review, and quality oversight of regulatory documentation (MAAs, responses, variations, renewals).
• Coordinate and support regulatory authority inspections, audits, and preparation activities.
• Maintain cross-functional relationships with R&D, Clinical Development, CMC, Quality, PV, Medical Affairs, Commercial, Legal.
• Manage external regulatory consultants and vendors; build networks with agencies and partners.
• Govern regulatory governance, quality control, and compliance across the process.
• Monitor timelines, deliverables, costs, and resource allocation; manage budgets.

Skills

Regulatory strategy

Project management

Stakeholder management

Leadership

Regulatory affairs

Education

Master’s degree or above in Pharmacy, Medicine, Biology, or related life science

Job description

EU Regulatory Strategy and Project Management

• Serve as the primary regulatory and scientific point of contact with the European Medicines Agency (EMA), national competent authorities in EU Member States, internal stakeholders, customers, consultants, and vendors.
• Develop and implement EU regulatory strategies and action plans in alignment with the company’s overall R&D and business objectives.
• Lead and coordinate EU registration activities for company products, including pre-marketing authorization and post-approval lifecycle management activities, where applicable.
• Oversee the progress, quality, and delivery of all EU regulatory projects; proactively identify challenges, assess risks, and drive resolution plans.
• Provide regulatory input to product development, commercialization, partnership discussions, and business-development activities.
• Lead the preparation, review, and quality oversight of regulatory documentation, including marketing authorization applications, responses to health authority questions, variations, renewals, and other lifecycle submissions.
• Coordinate and support regulatory authority inspections, audits, and related preparation activities.
• Establish and maintain effective working relationships with internal functions, including R&D, Clinical Development, CMC, Quality, Pharmacovigilance, Medical Affairs, Commercial, and Legal teams.
• Manage external regulatory consultants and vendors to ensure activities are conducted efficiently and in compliance with EU requirements.
• Build and maintain professional networks with European regulatory agencies, consultants, and relevant external partners.

Regulatory Operations, Quality, and Budget Management

• Ensure effective governance, quality control, and compliance throughout the regulatory affairs process.
• Monitor EU regulatory project timelines, deliverables, costs, and resource allocation.
• Manage regulatory budgets and oversee cost utilization across EU projects.
• Ensure regulatory activities comply with applicable EU laws, regulations, guidelines, and internal procedures.
• Drive continuous improvement of regulatory processes, planning tools, and submission quality standards.

Qualifications

• Master’s degree or above in Pharmacy, Medicine, Biology, or a related life science discipline.
• At least 10 years of relevant Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Strong knowledge of EU pharmaceutical regulations, registration pathways, and technical guidelines, including EMA and EU Member State requirements.
• Thorough understanding of the end-to-end drug registration process and experience in authoring, reviewing, and managing regulatory submission dossiers.
• Familiarity with GxP, ICH guidelines, and applicable quality and compliance requirements.
• Demonstrated experience communicating and interacting with EU regulatory authorities, including EMA and/or national competent authorities. Experience with other health authorities, such as the NMPA or FDA, is preferred.
• Proven experience in regulatory risk assessment, feasibility evaluation, issue resolution, and strategic planning.
• Strong leadership, project-management, stakeholder-management, and cross functional collaboration skills.
• Ability to manage multiple complex projects and external resources in a fast paced, matrixed environment.
• Fluent written and spoken English. Proficiency in additional European working languages is a plus.