Regulatory Affairs Specialist

hace 1 semana


madrid, España Eurofins A tiempo completo

Regulatory Affairs Specialist - Group Leader - Crop Protection Full-time Eurofins Scientific is an international life sciences company that offers customers from various industries a unique range of analytical services to make life and our environment safer, healthier and more sustainable. From the food you eat to the water you drink to the medicines you rely on, Eurofins works with the world's largest companies to ensure the products delivered are safe, theirs Ingredients are authentic and labeling is accurate. The company is a leading global provider of analytics for food, environmental, pharmaceutical and cosmetic products as well as contract research (CRO) services. Eurofins has more than 900 laboratories within its global network, employing over 62’000 staff. Eurofins Professional Scientific Service® (PSS) is a global insourcing solution for our customers. Together with the customer, we define a project for the required services that our Eurofins employees should provide. During the ongoing project, the responsibility for project management, the previously defined services and the deployment of our employees in this project lies with Eurofins PSS. This role offers the flexibility to work remotely from any of the following locations: several EU countries, the UK and Switzerland. As a member of the EU Product Registration Team within Europe Crop Protection Regulatory Operations, you will: Support the management of crop protection product registration dossiers under EU Regulation 1107/2009. Review regulatory dossiers to ensure compliance with client quality standards and EU requirements. Act as a liaison to collect and manage registration requirements and contribute to business process development with regulatory experts across Europe. Key Responsibilities: Work with the Europe Regulatory Manager and project teams to obtain and maintain EU Member State authorizations for crop protection products Represent regulatory and safety positions in project teams and facilitate business decisions Manage relationships with internal and external stakeholders, including regulatory authorities and cross-functional teams Lead planning, submission, and post-submission activities for new formulations and product renewal programs Develop project plans to ensure timely and quality delivery of regulatory submissions Contribute expertise to improve regulatory processes and lead initiatives for efficient ways of working. Share knowledge and mentor others as your experience grows Coordinate and manage team members working remotely to ensure that productivity, quality, documentation, working hours, and excellence are managed to maximum efficiency Developing, coaching, motivating and building team morale through effective team work Ensure that the customer receives the best possible service by continually reviewing best practice with regard to commercial and quality issues and ensuring 100% ethical working standards Communicate regularly with customer and Eurofins management to ensure information is shared effectively and actions are taken immediately Note: Initial projects will include mentoring support from a senior expert, with responsibilities expanding as experience is gained. Experience: Minimum 5 years in regulatory affairs or related fields In-depth knowledge of EU crop protection regulations and dossier requirements Experience with regulatory processes in the EU or its Member States Ability to anticipate and manage regulatory issues proactively Fluent in English for technical discussions and advocacy Education & Skills: BA/BS or higher in a scientific, IT, or business discipline (PhD preferred) Strong scientific background relevant to regulatory work Excellent planning, project management, and problem-solving skills Ability to deliver quality work under tight timelines Critical thinking and process-driven approach Strong communication and advocacy skills Understanding of Good Agricultural Practices (GAP) and crop protection product use in the EU Knowledge of another major European language is an advantage Willingness to travel within EAME Company Culture At Eurofins PSS, our company culture is deeply rooted in our four core values: Teamwork, Integrity, Superlative Customer Satisfaction, and Productivity. We believe in fostering a collaborative environment where every team member is encouraged to contribute their unique expertise and ideas. Our commitment to integrity drives us to uphold the highest ethical standards in all our endeavors. We strive for superlative customer satisfaction by understanding and exceeding our clients' expectations. Embracing productivity, we continuously seek innovative ways to streamline processes and deliver exceptional results. Together, these values form the foundation of a supportive and empowering workplace, enabling us to achieve excellence in everything we do. Opportunities for Growth As part of our commitment to employee development, we offer abundant growth opportunities at Eurofins PSS. You'll have access to learning and development programs, coaching & mentorship, and the chance to take on challenging projects, empowering you to achieve your professional aspirations. Equal Opportunity Employer Statement At Eurofins PSS, we are dedicated to being an equal opportunity employer, embracing diversity, and cultivating an inclusive workplace where every individual's unique background and perspective are valued, respected, and celebrated. Please note that as per Eurofins policy, we do not accept unsolicited resumes from third-party recruiters unless such recruiters were engaged to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that Eurofins will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity. #J-18808-Ljbffr



  • Madrid, Madrid, España NOVUMGEN A tiempo completo

    Job Title: Regulatory Affairs Specialist SpainFull Time PermanentLocation: Spain (Madrid)About NovumgenNovumgen is a rapidly expanding, science-driven pharmaceutical company committed to delivering high-quality, accessible medicines across global markets. Our diverse portfolio spans specialty generics, complex formulations, and innovative therapeutic...


  • Madrid, Madrid, España Johnson & Johnson MedTech A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...


  • Madrid, España Indero A tiempo completo

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...


  • Madrid, España Indero A tiempo completo

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...


  • Madrid, Madrid, España Indero (formerly Innovaderm) A tiempo completo

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...


  • Madrid, Madrid, España Indero A tiempo completo

    The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...


  • madrid, España Eurofins A tiempo completo

    A global life sciences company in Madrid is seeking a Regulatory Affairs Specialist - Group Leader for Crop Protection. This role involves managing regulatory registration dossiers, ensuring compliance with EU requirements, and mentoring team members. The ideal candidate has at least 5 years of experience in regulatory affairs, a strong scientific...


  • Madrid, España MaserGrup A tiempo completo

    Masergrup es un grupo empresarial internacional con presencia en distintos sectores, entre ellos el alimentario, especializado en el desarrollo, producción y distribución de productos de alimentación infantil y nutrición de alta calidad. El grupo destaca por su enfoque en la innovación, la seguridad y el cumplimiento normativo en mercados...


  • Madrid, España Norgine A tiempo completo

    **About Norgine** Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product...


  • Madrid, España ABACUS MEDICINE A tiempo completo

    A pharmaceutical company is seeking a Senior Regulatory Affairs Specialist in Madrid. You will ensure compliance by obtaining parallel trading licenses and preparing packaging materials. Candidates should have a relevant degree and at least 2 years of experience in the pharmaceutical industry. Proficiency in English and local language is required. This role...