Carlos Simon Foundation for Research in Women's Health
Date: 12 feb
Location: Paterna, Valencia, Spain
About the Organization: At Carlos Simon Foundation, we offer an outstanding Postdoctoral position in our research laboratory. The applicant will join a research team committed to investigating innovative methods for precise and early preoperative assessment of gynecological tumors. We are a multidisciplinary team made up of more than 30 professionals.
Our main activity is biomedical research in reproductive medicine and women's health, along with initiatives aimed at improving our knowledge in the field. We are affiliated with the University of Valencia and the INCLIVA Health Research Institute (IIS INCLIVA).
Key Accountabilities and Responsibilities:
1. Development and implementation of the Quality Management System (QMS):
* Ensure compliance with applicable regulations such as GMP, ATMP, and ISO 9001.
* Promote and implement improvement measures identified through KPI analysis, complaints, and CAPA systems.
* Perform internal audits.
* Act as company representative during external audits by regulatory authorities, partners, or customers.
* Draft and update regulatory documentation required for obtaining and maintaining registrations in all countries where the product is marketed.
* Manage relationships with EMA, AEMPS, and other regulatory authorities to obtain necessary licenses.
* Manage the maintenance of ODD (Orphan Drug Designation) for EMA and FDA therapies.
* Lead communications with authorities, including formal meetings, presentations, and responses to inquiries.
* Ensure regulatory compliance in target markets.
* Act as technical lead or deputy technical lead as designated.
* Act as Compliance Officer as designated.
1. Collaborate with Clinical Trials in preparing regulatory documentation for clinical trial authorization.
2. Ensure adequate data collection for regulatory compliance and dossier development.
Required Skills and Experience:
1. Advanced degree in health sciences (e.g., Pharmacy, Biochemistry, Biotechnology, Biology, etc.).
2. Minimum 5 years in quality and regulatory management, preferably with experience in advanced therapies (ATMP) or pharmaceuticals.
3. Demonstrated experience interacting with EMA, AEMPS, and other regulatory authorities.
4. Knowledge of applicable regulations, specifically Regulation 1394/2007/EC and Directive 2001/83/EC.
5. Relevant experience in at least one of the three areas: in vitro diagnostics, medical devices, and pharmaceutical development.
6. At least 2-3 years of regulatory and/or quality management experience in the indicated areas.
7. Effective communication with internal teams, suppliers, and regulatory authorities.
8. Analysis and resolution of regulatory and quality issues.
9. Experience in process and standards implementation.
10. Leadership and management of multiple projects simultaneously.
11. Professional command of English.
12. Limited travel availability (approximately once per quarter).
Labor Conditions:
Salary: The salary range will depend on the suitability of the candidate for the requested profile.
Contract: Full-time employment contract.
What Do We Offer?
Participate in a research project focused on women's health in a highly motivating team. Opportunity for professional and personal growth, as well as the application of knowledge working with colleagues in the same professional field.
Workplace:
Our facilities are in Parque Tecnológico de Paterna, Rda. de Narcís Monturiol, 11, Bloque C, 46980 Paterna, Valencia.
Application Process:
If you are interested, please send us your application.
Original announcement can be found at Kit Empleo.
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