Project Manager with Experience in Regulatory

hace 4 semanas


Bilbao, España LEADARTIS A tiempo completo

Empresa: LEADARTIS

- Nº de Plazas: 1
- Referencia: MANAGER REGULATORIO

- Publicada el 1/2/2023

- Publicada hasta el 1/5/2023
- Tipo de Contrato: Indefinido

- Dedicación: Jornada completa
- Localidad: Noain

- Provincia: Navarra

- Disponibilidad para viajar: Si
- Fecha de Incorporación: 1/3/2023

Nível Académico
Doctor

- Titulación Académica
Ciencias Biomédicas (Titulación Universitaria)

- Áreas tecnológicas
B-055 Inmunología

B-057 Oncología

- Idiomas
Idioma: Inglés

Nível Lectura: Alto

Nível Escrito: Alto

Nível Conversación: Alto

- Conocimientos de Informática
- Office
- Experiência
- Profile
PhD in biomedical field: Medicine, pharmacy, biotechnology, biology, biochemistry etc.
Independent professional with strong interpersonal and teamwork skills
Profile with immuno-oncology expertise, experience with antibodies preferred with bispecific format.
Previous professional experience in regulatory affairs, CMC and GLP NHP studies.
IMPD/IND submission experience
Very high level of spoken and written English
- Otros
- This individual will work closely with the CEO for the assigned program(s) to ensure consistent high quality and meet agency requirements and guidelines.

The Responsibilities will include the following:

- Serve as the regulatory representative providing input and guidance to ensure studies are appropriately designed and implemented to meet global regulatory requirements. Coordinate with team members to address inquiries from Health Authorities.
- Preparation, writing and submission of regulatory documents IMPD/IND amendments, responses to Health Authority inquiries, and other regulatory submissions as required in collaboration with appropriate leadership.
- Support the regulatory agency meetings including meeting planning and ensuring submitted documents are compliant and of the highest quality. This includes working with the CEO to develop, prepare and manage content and timelines for Agency meeting requests, etc.
- Provide input to accomplish specific regulatory deliverables, working with the CEO to achieve stakeholder alignment and meeting quality and timeline goals.
- Manage timelines for regulatory submissions related to commitments and responses to inquiries.
- Assessing regulatory risk assessments and develop and recommend mitigation strategies to ensure that program activities are appropriately designed and implemented to meet global regulatory requirements.
- Monitor emerging trends regarding industry regulations and communicate and provide guidance to the leadership team on any regulatory changes to assure continued compliance.


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