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Regulatory Affairs Junior Officer/Trainee

Regulatory affairs Junior Officers/Trainees ensure and provide support for the appropriate registering, licensing, marketing, and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products. Combination of scientific knowledge, legal and business issues, ensure products, which are developed, manufactured, or distributed by a wide range of companies, meeting the required legislation.

Regulatory Affairs

Full Time

Madrid, Spain

Experience required:

At least 1 year of experience in a similar work position for junior officers, no experience required for trainees.

Duties required:

Audit and update of regulatory correspondence files/logs, and submission archives
Assist on product registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralised, Decentralised and Mutual Recognition Procedures).
Ensure regulations compliance (National and European regulations) for all Qualitec and other companies’ products.
eCTD compilation.
Collect and evaluate scientific data.
Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.
Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.
Advise clients and manufacturers on regulatory requirements.
Work with specialist computer software and resources (eCTDmanager, Lorenz eValidator, RAEFAR, GESFARMA, etc).
Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity.

Education and skills required:

B.Sc. degree in life science (Chemistry, Biology, Pharmacy, etc).
Master or related course in Regulatory Affairs.
English level: High.

CTA

A Clinical Trial Assistant (CTA) will manage administrative tasks throughout the life stages of a clinical trial, supporting the QF Local Study Team with the submission, collecting, listing, maintaining, tracking and updating (as corresponds) of trial related documentation; being a relevant liaison with other parties of the clinical study (Health Authorities, research sites, CRAs and Sponsor, when applicable).

Clinical Operations

Full Time

Madrid, Spain

Experience required:

At least, 1 year at similar position.

Duties required:

Supporting, the Local Study Team collecting and tracking the documents and data required for regulatory submissions (contracts, financial agreements, patient informed consent forms, insurance certificates).
Performing study submission to Health authorities, initial, amendments, notifications, etc.
Maintaining and updating of the Trial Master File and preparation for relevant QC checks when applicable
Tracking site budget related matters, including processing invoices, tracking payments and for scheduling meetings, updating Excel trackers, coordinating the translation of site documents.
Train CTA trainees, if applicable.

Education and skills required:

Postgraduate studies or course of Clinical Trial Assistant (or equivalent), ongoing or finished.
Good command of written English.
Excellent organizational and prioritization skills.
Knowledge of Microsoft Office programs.
Attention to detail and excellent oral and written communication skills.

Senior CRA

Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites, perform on-site visits and training and mentoring of CRAs with less experience. Supporting activities to CTM regarding project management.

Clinical Operations

Full Time

Madrid, Spain

Experience required:

At least 2 years in a similar position.

Duties required:

Perform site selection, SIV, IMV and COV in clinical studies of new and established pharmaceuticals. Experience in oncology trials is highly valued.
Responsible for support and management of sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
Obtain, maintain and review applicable clinical documentation in a timely manner.
Prepare and attend investigator meetings.
Participate in hosting pertinent audits/inspections when necessary.
Training and mentoring of CRAs with less experience.
Eventual support in the writing of company procedures.

Education and skills required:

Degree in life sciences or equivalent.
Master of Clinical Trials Monitoring.
Proven track record as an accomplished CRA in IMP trials (at least 4 years).
English: Fluent spoken & written.
Excellent communication and time management skills to manage multiple projects at any one time.
Strong team member and understand the need for effective communication at all levels.
Effective relationship building with sponsors, sites and colleagues, as well as strong management skills.
Responsible person, able to work with autonomy, dynamic and well organized.
Must be able to travel in accordance with company and project requirements.

CRA

Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites and perform on-site visits.

Clinical Operations

Full Time

Madrid, Spain

Experience required:

At least 1 year in a similar position.

Duties required:

Perform in site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation.
Support and management of the sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
Managing progress by tracking case report form (CRF) completion and data query resolution.
Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.
Cooperating and/or writing study plans and manuals.

Education and skills required:

Bachelor’s degree, or equivalent, in a scientific or healthcare discipline.
Master of Clinical Trials Monitoring.
Understanding of SOPs, WIs, EU, and local regulations as well as ICH GCP guidelines.
Good command of written and spoken English language.
Computer skills including use of Microsoft Word, Excel, and PowerPoint.
Willingness and ability to travel.
Responsible person, dynamic and organized, good team player.