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Work with us

Job Offers

Senior Regulatory Affairs Officer

Supervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Coordinate junior staff.
Full Time

Madrid, Spain

Experience required:

At least 2 years in a similar work position.

Duties required:

  • Assist on products 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 (Centralized, Decentralized and Mutual Recognition Procedures).
  • Ensure regulations compliance (on both European and local regulations) for all QualitecFarma® and other companies’ products.
  • eCTD compilation
  • Collect and evaluate scientific data.
  • Prepare labelling, PIL, SmPC and mock-ups of medicinal products, and adaptation to current QRDs.
  • Provide strategic advice throughout the development of new products.
  • Managing teems of colleagues involved with the development of new dossiers.
  • 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 Validator, RAEFAR, etc).
  • Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity for the approval of client’s medicinal products in Spain and other countries, as needed.

Education and skills required:

  • B.Sc degree in life science (Chemistry, Biology, Pharmacy, etc).
  • Master or related course in Regulatory Affairs will be desirable.
  • English level: High (spoken and written).

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).
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.
Full Time

Madrid, Spain

Experience required:

At least 1 year in a similar position.

Duties required:

  • Perform site selection, SIV, IMV and COV in clinical studies of new and established pharmaceuticals.
  • 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.
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.

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