Esta oferta de trabajo no está disponible en tu país.
Senior Director, Regulatory Affairs
VeristatMálaga, Andalucía, EspañaHace 9 días
Descripción del trabajoThe estimated hiring range for this role is € 125k- 155K plus applicable bonus. This hiring range is specific to Europe (Ireland, France, Germany and Spain) and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to : skills and experience, licensure and certifications, education, specific location and dynamic market data. Benefits vary by location and may include : Remote workingFlexible time offPaid holidaysMedical insuranceTuition reimbursementRetirement plans Master’s degree in science, toxicology, pharmacology, engineering or related field; Ph.D. preferred, with applied training relevant to Regulatory Affairs. 10+ years of experience in Regulatory Affairs at Pharma and CRO / Consultancy level, with a minimum 8 years of supervisory experience required. Direct experience creating and implementing the strategic direction of a company or business unit. Excellent understanding of regulatory procedures and guidelines, such Pediatric Investigation Plans, Orphan Drug Designations, Scientific Advice, Marketing Authorization Applications for the EU, UK and CH. Additional regions a plus. Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research. Excellent written and oral communication skills including grammatical / technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials, PIPs, ODDs, SA and Marketing Authorization Applications are required. In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) / consultancy industry with pharmaceutical / biotech companies. Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff. Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications. Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment. Spain
Senior Director Regulatory Affairs : Leads the European Regulatory Affairs team and supports development of team members to become independent and efficient regulatory affairs professionals / consultants. Provides strategic and operational support to Veristat clients for filings and maintenance of healthcare products and supports regulatory decision-making from a strategic point of view; Supervises team performance of European RA team members and ensures deliverables are of high quality and meets the scope of the respective project and applicable regulatory requirements; Acts as line manager for European RA team members and oversees team budgets and team resources. Provides support for business development activities and client acquisition as needed. Acts as regulatory lead and contact person for SFL Pharma GmbH and SFL Pharmaceuticals Deutschland GmbH.
What we do
For more than 30 years, Veristat has built a reputation as global experts in clinical development.
- 760+ Rare Disease Clinical Trials supported
- 160+ Marketing Applications supported
- In 2022 we supported 8 marketing application that received regulatory approval
- Learn more about our core values here!
What we offer
What we look for
Automated Decision Making : All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
LI-RD1
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Senior Director, Regulatory Affairs
J-18808-Ljbffr
J-18808-Ljbffr
J-18808-Ljbffr
Crear una alerta de empleo para esta búsqueda
Director Regulatory • Málaga, Andalucía, España
Ofertas relacionadas
- Oferta promocionada
Regulatory Affairs Manager
buscojobs EspañaMálaga, Andalucía, España We are seeking a Regulatory Affairs Manager for the Quality & Environmental Team, reporting to the Quality & Environmental Director.
This is a new position within a growing team, involving collabora...Mostrar másÚltima actualización: hace 3 días
- Oferta promocionada
Quality Assurance Regulatory Affairs Manager
elemedmálaga, España You may be required to travel on 3-4 days per month.Interim - 3-6 months - Immediate Start.A leading global MedTech organisation is strengthening its footprint across Western and Southern Europe, e...Mostrar másÚltima actualización: hace 15 días
- Oferta promocionada
Regulatory Affairs Data Manager
Galdermamálaga, España Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries.We deliver an innovative, science-based portfolio of premium flagship brands and services that ...Mostrar másÚltima actualización: hace 19 días
- Oferta promocionada
Purchasing Director
Page Executivemálaga, España Work in a cross-functional role with high visibility and decision-making power.Lead and shape procurement in a growing pharma environment.
A pharmaceutical company undergoing significant growth and ...Mostrar másÚltima actualización: hace 17 días
- Oferta promocionada
50690 - Regulatory Affairs Manager
mainmálaga, España Somos una empresa biotecnológica centrada en el desarrollo de soluciones genómicas innovadoras para la medicina de precisión en oncología.
Estamos buscando un / a GERENTE DE ASUNTOS REGULATORIOS par...Mostrar másÚltima actualización: hace 13 días
- Oferta promocionada
Senior Director Medical & Clinical Affairs EMEA-LATAM
Dexcommálaga, España Senior Director Medical & Clinical Affairs EMEA-LATAM.Senior Director Medical & Clinical Affairs EMEA-LATAM.Senior Director Medical & Clinical Affairs EMEA-LATAM.
Senior Director Medical & Clinical ...Mostrar másÚltima actualización: hace 1 día
- Oferta promocionada
Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs)
Novartis FarmacéuticaMálaga, Andalucía, España Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs).This role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, p...Mostrar másÚltima actualización: hace 11 días
- Oferta promocionada
Regulatory Affairs Senior Specialist EMEA M / F
Vèringer Engineeringmálaga, España The Centre for Genomic Regulation (CRG) is an international biomedical research institute of excellence, based in Barcelona, Spain, with more than 400 scientists from 44 countries.The CRG is compos...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Director Regulatory Compliance
North Search Talent PowerhouseMálaga, Andalucía, España North Search is a leading international talent consultancy, partnering with organizations across rapidly changing sectors to deliver outstanding talent and innovative leadership.We are excited to a...Mostrar másÚltima actualización: hace 9 días
- Oferta promocionada
Regulatory Affairs Manager
G&L Scientificmálaga, España Direct message the job poster from G&L Scientific.Senior Manager - Talent Acquisition - Sourcing the best candidates across EMEA & APAC.
Are you an experienced Regulatory Affairs professional? Join ...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Regulatory Affairs Lead- FSP
Thermo Fisher ScientificMálaga, Andalucía, España Join to apply for the Regulatory Affairs Lead- FSP role at Thermo Fisher Scientific.Join to apply for the Regulatory Affairs Lead- FSP role at Thermo Fisher Scientific.
At Thermo Fisher Scientific, ...Mostrar másÚltima actualización: hace 11 días
- Oferta promocionada
Senior / Medical Director (Ophthalmology) 0.5 FTE
TFS HealthSciencemálaga, España Senior / Medical Director (Ophthalmology) 0.Senior / Medical Director (Ophthalmology) 0.Senior / Medical Director (Ophthalmology) 0.
Be among the first 25 applicants.Senior / Medical Director (Ophthalmology...Mostrar másÚltima actualización: hace 8 días
- Oferta promocionada
Biologics Regulatory Affairs Specialist
beBeeRegulatoryAffairsMálaga, Andalucía, España We are seeking a seasoned biologics regulatory affairs specialist to join our team.As a key member of our team, you will be responsible for ensuring the successful global registration and lifecycle...Mostrar másÚltima actualización: hace 2 días
- Oferta promocionada
Country Medical Director Iberia
CSL Plasma Inc.málaga, España Country Medical Director Iberia.CSL Vifor is currently looking for a Country Medical Director Iberia to be based at our office in Barcelona.
CSL Vifor is a global leader in nephrology, iron deficien...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Regulatory Affairs Officer
ASPHALIONmálaga, España Get AI-powered advice on this job and access more exclusive features.Direct message the job poster from ASPHALION.Asphalion is growing, and we are looking for a Regulatory Affairs Officer with expe...Mostrar másÚltima actualización: hace 7 días
- Oferta promocionada
Regulatory Affairs Manager
GL Scientificmálaga, España Are you an experienced Regulatory Affairs professional? Join our team as a Regulatory Affairs Manager and play a vital role within G&L Scientific team.
This role focuses on cross-functional activiti...Mostrar másÚltima actualización: hace 2 días
- Oferta promocionada
Regulatory Affairs Project Manager
Parexelmálaga, España When our values align, there's no limit to what we can achieve.We are seeking a dynamic and experienced Regulatory Affairs Project Manager to join our team.
This role offers the flexibility of being...Mostrar másÚltima actualización: hace 2 días
Regulatory Affairs Project ManagerNonStop Consulting
NonStop ConsultingSpain Regulatory Affairs Project Manager.Location : Remote / Home Working EU Wide.Our client is seeking a highly skilled and motivated Regulatory Affairs Project Manager to join their dynamic team.This role...Mostrar másÚltima actualización: hace más de 30 días