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 company'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.