Senior Specialist, European Country Regulatory Affairs

bioM?rieux BV; Madrid; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Madrid seeks a Regulatory Affairs professional with a university degree in life sciences and a minimum of 5 years experience in the pharmaceutical industry. The role involves supporting regulatory activities to maintain marketing authorisations and manage product registrations across Europe. Strong project management, communication skills, and proficiency in regulatory systems are essential for this position. A knowledge of additional European languages is a plus.

Formación

• Minimum of 5 years of experience in the pharmaceutical industry.
• Extensive involvement in registration processes across multiple European markets.
• Ability to operate with minimal oversight.

Responsabilidades

• Coordinate regulatory activities for marketing authorisations.
• Oversee preparation and review of regulatory documentation.
• Ensure compliance of marketing authorisations.
• Develop and implement regulatory strategies.

Conocimientos

Fluency in written and spoken English

Proficiency in at least one additional European language

Proficient in regulatory information management systems

Strong verbal and written communication skills

Excellent organizational and planning abilities

Meticulous attention to detail

Adaptability to manage conflicting deadlines

Mature and professional approach

Ability to collaborate across functions

Capable of working independently

Educación

University graduate in life sciences, preferably pharmacy/pharmacology

Herramientas

Veeva

Ennov

Power BI

Descripción del empleo

Job Description

The Position

Coordinating and supporting all regulatory activities to maintain registrations and to obtain new marketing authorisations for the company portfolio/pipeline subject to EU procedures (Centralised, Mutual Recognition, Decentralised, National authorised Procedures) across therapeutic areas. The position also requires strong project management skills to oversee regulatory initiatives, manage timelines effectively, and facilitate collaboration within cross‑functional teams.

Responsibilities

• Ensure the maintenance of marketing authorisations across Europe for assigned products by preparing and submitting post‑approval applications in a timely manner, in collaboration with the GRL and European country affiliates.
• Coordinate, manage, and support regulatory activities across Europe, including EEA, Switzerland, the United Kingdom, and non‑EU EEI countries, as needed.
• Oversee the preparation and review of regulatory documentation to align with corporate objectives, maintaining interactions with relevant EU regulatory agencies, EMA and country regulatory affairs teams.
• Develop and implement regulatory strategies for registered products, development projects, and new marketing authorisation applications.
• Stay updated on relevant EU regulations and guidelines to provide expert regulatory advice.
• Represent European Regulatory Affairs on assigned non‑product related projects.
• Build and maintain strong relationships with internal and external stakeholders across regulatory and cross‑functional teams.
• Provide support for regulatory activities in non‑European countries as needed.
• Ensure the timely preparation and submission of appropriate documentation for new Marketing Authorisation Applications through CP, MRP, DCP, working closely with cross‑functional teams at regional and global levels, and country affiliates as needed.
• Maintain compliance of marketing authorisations with regulatory requirements by performing lifecycle management activities, including but not limited to preparation and submission, with a high standard of quality and within agreed timelines, supporting country affiliates where necessary; support complex submissions like groupings, super‑grouping and work‑sharing for CP/MRP/DCP/NAPs and mixed procedures.
• Review and confirm variation classifications while supporting complex regulatory submissions.
• Prepare supportive administrative documents and review submissions where required.
• For labelling variations, coordinate labelling requests with the Labelling Team and prepare the necessary product information.
• Oversee the authoring and timely submission of response documents to Health Authority queries.
• Ensure regulatory milestones for assigned projects are achieved and effectively communicated to stakeholders.
• Provide regulatory input and expertise during internal functional and cross‑functional governance meetings, as required.
• Act as the local or regional Regulatory Affairs representative on assigned cross‑functional teams for non‑product‑related initiatives.
• Develop and implement efficient processes to meet business objectives while ensuring compliance with regulatory requirements.
• Understand downstream impact of regulatory changes to local country functions.
• Maintain strong scientific knowledge and expertise in all assigned product areas, staying updated on regulatory changes that may influence company strategy.
• Adhere to company leadership principles and compliance standards in all daily activities; build and sustain effective working relationships with relevant regulatory authorities.
• Collaborate as a committed member of the European Regulatory Affairs team, contributing to both functional and cross‑functional projects.

Required Education, Experience, and Skills

Education / Certificates

University graduate in life sciences, preferably pharmacy/pharmacology.

Skills (professional and/or technical)

• Fluency in written and spoken English is essential, with proficiency in at least one additional European language being highly desirable.
• Proficient in using regulatory information management systems and tools, including Veeva, Ennov, Power BI, as well as standard office applications such as word processing, spreadsheets, database software, and internet‑based tools.

Competencies

• Strong verbal and written communication skills are essential, along with excellent organizational and planning abilities.
• Demonstrates meticulous attention to detail and adaptability to manage conflicting deadlines and high workloads effectively.
• Exhibits a mature and professional approach to work, with a clear understanding of the commercial significance of the role.
• Proven ability to collaborate with colleagues across all levels and functions, both within Europe and internationally, with potential to take on leadership responsibilities.
• Capable of working independently and as part of a team across a wide geographic scope.

Experience

• A minimum of 5 years of experience in the pharmaceutical industry or a comparable field, with extensive involvement in registration processes across multiple European markets and practical expertise in managing European regulatory procedures.
• Adequate subject matter knowledge to operate with minimal oversight from the Manager.

At Organon Spain we have a current local Gender Equality Plan that ensures equal treatment and opportunities for all our employees and candidates.