Regulatory Information Associate, Regulatory Operations & Systems Management

Overview The Regulatory Information Associate, Regulatory Operations & 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.

Responsibilities 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 in 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.

Provide 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. Flexible start time from Monday to Friday (full-time).

Benefits Benefits and Savings Club.

Training and language learning platform.

Wellness platform with unlimited free psychologist sessions.

Development plans, internal mobility policy.

What will the Selection process be like? Stay tuned to your phone and email. The first step is likely to be contact through one of the channels.

Prepare well. We will continue with an in-person / virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and there may also be some kind of test.

Wait for the result. We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Commitment to Equal Opportunities Our group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter. We do not discriminate on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

Seniority level Associate

Employment type Full-time

Job function Information Technology and Other

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