Position : Regulatory Information Associate, Regulatory Operations & Systems Management
Location : Madrid (on site)
Experience : 3 to 5 years’ experience in regulatory or regulatory operations in the biotech or pharmaceutical industry.
Want to know more?
The Regulatory Information Associate, Regulatory Operations and Systems Management is responsible for managing and overseeing Product Regulatory Information, ensuring its integrity within Business Processes and compliance with regulations worldwide.
The role reports to the Associate Director, Regulatory Operations & Systems Management.
The challenge!
Product Regulatory Information
* Assist in developing and implementing standardized data management strategies, processes, and tools.
* Collaborate with key stakeholders to gather data requirements and define data principles that meet business needs.
* Provide guidance on data architecture, including data modeling, database design, and integration processes.
* Support the management of Product Regulatory Data to maintain data integrity and compliance with IDMP standards.
* Perform Data Entry tasks within the RIM System accurately and efficiently.
* Promote a data-driven culture through education and guidance on data best practices, ensuring adherence across the organization.
* Assist in Data Quality Checks and Data Analysis to meet quality standards.
* Support the Systems Administrator by identifying potential improvements and participating in their deployment.
Other responsibilities
* Ensure the compilation and publishing of global submissions in electronic Common Technical Document (eCTD), including IND/CTA, BLA/MAA submissions to FDA, EMA, PMDA, and others, ensuring compliance with local agency requirements.
* Manage regulatory correspondence, records, and submission lifecycle processes.
* Prepare export documentation for global submissions, such as Certificates of Pharmaceutical Product, Power of Attorney, and legalization procedures.
* Provide guidance and expertise on Regulatory Operations to internal and external stakeholders.
* Participate in creating and revising ad-hoc Quality Documentation.
What do you need?
* Education: Bachelor’s degree in computer science, technology, Health Sciences (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent.
* Languages: Fluent English (oral and written); knowledge of Spanish and other languages is a plus.
* Experience: 3 to 5 years in regulatory or regulatory operations within biotech or pharmaceutical industries.
* Specific Knowledge:
o Experience with RIM System, including data entry, maintenance of product information, and document management.
o Experience with preparation, publishing, and submission of eCTD for IND/CTA, BLA/MAA, including interactions with health authorities and lifecycle management of eCTD submissions.
o Knowledge of EMA, FDA, and ICH regulations and guidelines on eCTD structure and specifications.
* Travel: 5%
* Personal Skills:
o Self-motivated, open to new challenges, and adaptable.
o Strong communication, interpersonal, and cross-functional collaboration skills.
o Ability to work in a dynamic, fast-paced environment.
Our benefits!
* Flexible start times from Monday to Friday (full-time).
* Permanent contract.
* Attractive salary package.
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