Regulatory Affairs Manager at UltraCon Consultoria

Descrição da Função:

Últimas informações de emprego de UltraCon Consultoria para o cargo de Regulatory Affairs Manager. If the Regulatory Affairs Manager vaga em Lisboa corresponde às suas qualificações, submeta a sua candidatura ou CV atualizado diretamente através do portal Jobkos.

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We're Hiring: Senior Regulatory Affairs Manager – Biological Products (EU Market)

Are you a strategic Regulatory Affairs professional with strong expertise in biologicals and bioinputs within the European market? This is an opportunity to play a key role in shaping regulatory strategy and supporting business growth at a leadership level.

Your Mission

As a senior regulatory leader, you will act as a strategic advisor to executive leadership during the development of new biological products, ensuring regulatory feasibility, risk assessment, and alignment with European market launch timelines.

Key Responsibilities

• Act as a strategic consultant to leadership during new biological product development, assessing regulatory viability, risks, and impact on EU market launch timelines.
• Actively contribute to marketing concept development and review/approve packaging, labeling, technical materials, and advertising to ensure compliance with EU legislation.
• Collaborate with global regulatory teams to overcome regulatory barriers, driving solution-oriented outcomes.
• Stay continuously updated on European legislation for biologicals and bioinputs through technical forums, industry events, and regulatory authority interactions.
• Lead complex regulatory authorization processes, ensuring robust risk assessment and compliance.
• Manage outsourced regulatory trials (when approved), including study plan approval, monitoring, and validation of final reports prior to submission.
• Prepare, review, and submit regulatory dossiers; monitor registration processes with European authorities.
• Develop strong technical and scientific arguments for new registrations and license renewals.
• Evaluate regulatory, scientific, and operational risks, ensuring mitigation strategies are implemented.
• Maintain frequent interaction with senior leadership (C-Level), ensuring strategic alignment across departments.
• Align regulatory programs and tools with the Empresa's European growth and expansion strategy.

Technical Expertise

• In-depth knowledge of EU legislation applicable to biological products and bioinputs (EU regulations, national frameworks, best practices).
• Strong understanding of risk assessment, scientific and technical requirements, efficacy, safety, and quality studies.
• Proven experience managing regulatory processes: registrations, renewals, maintenance, and dossier submissions to European authorities.
• Experience with medium to high-complexity regulatory projects, including risk analysis and mitigation strategies.
• Technical interaction with authorities, consultancies, and external partners.
• Regulatory review of labeling, packaging, and promotional materials.
• Interpretation and implementation of regulatory changes impacting product portfolios.
• Solid background in Regulatory Affairs, specifically in biologicals, bioinputs, or biocontrol.

Education

• Bachelor's degree in Agronomy, Biology, Biotechnology, Chemistry, Pharmacy, Agricultural Engineering, or related fields.
• Postgraduate degree or specialization is a plus.

Behavioral Competencies

• Strategic mindset with strong analytical skills to anticipate and influence regulatory changes.
• Recognized as a technical reference and internal consultant across departments.
• Technical leadership with influence and ability to guide others, even without direct people management.
• Highly organized, autonomous, and capable of managing multiple complex projects simultaneously.

If you are ready to take a strategic leadership role in Regulatory Affairs within the biologicals sector, we would love to hear from you.

Feel free to reach out directly or apply via message.

Informação da Vaga:

• Empresa: UltraCon Consultoria
• Cargo: Regulatory Affairs Manager
• Local de Trabalho: Lisboa
• País: PT

Como enviar a sua candidatura:

Após ler e compreender os critérios e requisitos mínimos explicados na informação da vaga Regulatory Affairs Manager at the office Lisboa acima, prepare de imediato os documentos de candidatura, tais como carta de apresentação, CV, cópia do diploma e outros anexos. Envie através do link 'Próxima Página' abaixo.