Regulatory Affairs Specialist - Human Health

We are looking for an analytical, organized profile with high attention to detail, capable of managing different priorities and deadlines without losing sight of regulatory compliance.

An autonomous and proactive person, with the ability to solve problems and propose practical solutions, but also curious and eager to learn in an international and constantly evolving environment.

We are looking for a Regulatory Affairs profile oriented toward human health, with experience in the life sciences industry and the ability to operate in an international environment.

The selected person must have an interest in contributing to the regulatory development and maintenance of biological medicines intended for human health, as well as in continuing to grow within the Regulatory Affairs area.

Requirements

• At least 2 years of professional experience in a Regulatory Affairs position within the life sciences industry.
• Experience in the biotechnology sector and in product registration processes will be especially valued.
• Fluent level of English and Spanish, both oral and written.
• Proficiency in IT tools such as Outlook, Word, Excel, and PowerPoint.
• Availability to travel occasionally, approximately 10 % of the time.

Would you like to participate in the development and maintenance of biological products intended for human health in an international environment and contribute to ensuring they can meet all the necessary requirements to reach the markets?

At Biofabri, we are going to incorporate a Regulatory Affairs Specialist to contribute to guaranteeing the regulatory compliance of our biological products intended for human health, working with different markets and in coordination with Competent Authorities and internal and regional Regulatory Affairs teams.

You will be a key piece in the management and maintenance of the regulatory registrations of the company's biological medicines for human health, ensuring that documentation and applicable requirements are kept up to date and providing support to the different regulatory needs of the business.

You will work in an international environment, collaborating with the Competent Authorities of the assigned countries and with the EMEA Regulatory Affairs team.

Your main responsibilities will include:

• Manage and maintain the regulatory notifications and registrations of biological medicines for the different product lines.
• Act as an interlocutor with the Competent Authorities of the assigned countries and provide support for regulatory communications.
• Review scientific and clinical literature to support product registrations and contribute to the continuous compliance of applicable regulatory requirements.
• Keep databases, regulatory registrations, requirements for each country, and documentation associated with products up to date.
• Monitor regulations, standards, and regulatory guides, identifying news that may impact the business and communicating it to the team.
• Provide regulatory support in tender processes, ensuring complete responses within the established deadlines.
• Represent the Regulatory Affairs area in internal and external meetings, including those related to industry associations, following up on agreed actions.
• Provide regulatory support at a regional level and keep shared platforms up to date, such as network drives and SharePoint.
• Periodically report progress to the EMEA Regulatory Affairs team.