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 the management and oversight on the Product Regulatory Information, ensuring its integrity with the Business Processes and the regulations, worldwide.
The role reports to the Associate Director, Regulatory Operations & Systems Management.
The challenge!
Product Regulatory Information
* Assist in the development and implementation of standardized data management strategies, processes and tools.
* Collaborate with key stakeholders to gather data requirements and contribute to the definition of data principles that address business needs.
* Provide guidance on data architecture aspects such as data modeling, database design, and integration processes.
* Support the management of Product Regulatory Data to maintain data integrity and ensure compliance with IDMP standards.
* Perform Data Entry tasks within the RIM System, accurately and efficiently.
* Promote a data-driven culture by providing education and guidance on data best practices and ensuring adherence across the organisation.
* Assist in conducting Data Quality Checks and Data Analysis to ensure that data quality standards are met.
* Support the Systems Administrator by identifying potential improvements and participating in their deployment.
Other
* Ensure the compilation and publishing of global submissions in Electronic Common Technical Document (eCTD), including but not limited to IND/CTA, BLA/MAA to FDA, EMA, PMDA and non-eCTD submissions for other regulated markets. Ensuring submissions are built in compliance with local agency requirements.
* Participate to the Management of regulatory correspondence, records, and submission life cycle management.
* Participate in the Preparation of export documentation to support global submissions including but not limited to Certificates of Pharmaceutical Product, Power of Attorney, and applicable legalization procedures.
* Provides guidance and expertise on Regulatory Operations to both internal and external stakeholders.
* Participate in the creation and revision of the ad-hoc Quality Documentation
What do you need?
* Education: Bachelor´s degree in computer science or technology or Health Sciences (e.g., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent.
* Languages: Fluent English required (oral and written); knowledge of Spanish and other languages will be an asset.
* Experience (years/area): 3 to 5 years’ experience in regulatory or regulatory operations in the biotech or pharmaceutical industry.
* Specific Knowledge:
* In the RIM System on Data entry and Maintenance of Approved Product Information details and on the management of Documents and Dossiers
* In the preparation, publishing, and eCTD submission for IND/CTA, BLA/MAA to regulatory agencies, including interactions with Health Authorities and lifecycle management of eCTD submissions. Direct hands-on experience working with document management systems, document formatting and publishing tools, eCTD validation and viewers.
* Knowledge of EMA, FDA and ICH regulations and guidelines on eCTD structure and specifications.
* Travels: 5%
* Personal skills:
* Self-motivated and open to new challenges.
* Ability to act with agility and speed.
* Strong communication skills (oral, writing and presentation)
* Strong interpersonal skills, ability to work cross-functionally and comfortable working in a dynamic fast-paced work environment.
Our benefits!
* ⏰ Flexible start time from Monday to Friday (full-time).
* Permanent contract.
* Attractive salary package.
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