Regulatory Affairs and Quality Specialist (Pharma)
About CARLOS SIMÓN FOUNDATION FOR RESEARCH IN WOMEN’S HEALTH
At Carlos Simon Foundation, we are offering an outstanding Postdoctoral position in our research laboratory, based in Paterna, Valencia (Spain). The applicant will join a research team that is committed to investigating innovative methods to shift the diagnostic and therapeutic focus towards a precise and early preoperative assessment of gynecological tumors.
The Carlos Simon Foundation for Women's Research is a non-profit organization founded and directed by Professor Carlos Simón, professor at the University of Valencia and renowned clinical researcher in the field of obstetrics and gynecology.
We are a multidisciplinary team made up of more than 30 professionals. We work to create a world in which women's health pathologies that affect the uterus are no longer a barrier to their quality of life and reproductive desire. Our main activity is biomedical research in the field of reproductive medicine and women's health, and the development of other initiatives and actions aimed at improving our knowledge in the field and its application.
Key Accountabilities and Responsibilities:
1. Development and implementation of the Quality Management System (QMS):
2. Develop and implement the Quality Management System (QMS) ensuring compliance with applicable regulations such as GMP, ATMP and ISO 9001.
3. Promote and implement improvement measures identified through the analysis of KPIs, complaints and CAPA systems.
4. Perform internal audits. Act as company representative during external audits performed by regulatory authorities, partners or customers.
5. Draft and update specific regulatory documentation required to obtain and maintain registrations in all countries where the product is marketed (UKCA,...).
6. Manage the relationship with EMA, AEMPS and other regulatory authorities to obtain all necessary licenses.
7. Manage the maintenance of ODD (Orphan Drug Designation) for EMA and FDA of the therapies.
8. Lead communications with authorities, including formal meetings, presentations and response to inquiries.
9. Ensure regulatory compliance in target markets in a sequential manner.
10. Act as technical lead or deputy technical lead in the company as designated. Assumes responsibilities as detailed in the line manager annex.
11. Acts as Compliance Officer in the company, as designated. Assumes the responsibilities detailed.
12. Collaborate with Clinical Trials in the preparation of regulatory documentation for clinical trial authorization.
13. Ensure adequate data collection for regulatory compliance and dossier development.
Required Skills and Experience:
1. Advanced degree, preferably with a 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. Demonstrated experience interacting with EMA, AEMPS and other regulatory authorities.
3. Knowledge of applicable regulations, specifically Regulation 1394/2007/EC and Directive 2001/83/EC.
4. Relevant experience in at least one of the three areas of expertise indicated: in vitro diagnostics, medical devices and pharmaceutical development.
5. At least 2-3 years of regulatory and/or quality management experience in at least one of the three areas of expertise indicated: in vitro diagnostics, medical devices and pharmaceuticals (or related area of expertise).
6. Effective communication with internal teams, suppliers and regulatory authorities.
7. Analysis and resolution of regulatory and quality issues.
8. Experience in process and standards implementation.
9. Leadership and management of multiple projects simultaneously.
10. Professional command of English.
11. Limited travel availability (approximately once per quarter). Occasional supplier visits and international regulatory audits.
Labor Conditions:
• The salary range for this position will depend on the suitability of the candidate for the requested profile.
What Do We Offer?
• Participate in a research project framed within women’s health in a highly motivating team.
• Opportunity for professional and personal growth, as well as the application of knowledge working with colleagues from the same professional field.
Application Process:
If you are interested, we would appreciate it if you could send us your application.
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Legal
Industries
Research Services
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