Oportunidad de desarrollo en AstraZeneca Argentina. Somos una compañía biofarmacéutica global e innovadora centrada en el descubrimiento, desarrollo y comercialización de medicamentos bajo prescripción médica. Desarrollamos nuestra actividad en importantes áreas de la atención sanitaria a las que pertenecen algunas de las enfermedades más graves del mundo: enfermedades cardiovasculares y metabólicas, respiratorias y oncología. Operamos en más de 100 países y nuestros medicamentos innovadores son usados por millones de pacientes en todo el mundo.
Position: Regulatory Affairs Manager.
Report to: Medical Director
Main Responsabilities:
- Provides strategic and operational regulatory leadership to the development, commercialisation and life cycle management of the assigned products in product teams.
- Provides effective lobbying and influencing on regulatory agencies and trade associations on product and legislative development issues and monitors changes in the regulatory environment in nominated region to support and advise relevant functions.
- Provides strategic regulatory advice support for product developments regional therapy area.
- Ensures adequate risk assessments and mitigation plans are included in the regulatory strategy documents.
- Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations.
- Ensures effective collaboration across the global, regional and local Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities.
- Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
- Ensures all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps. Provide support and advice on training and development to ensure all regulatory personnel in markets have an appropriate knowledge of quality and compliance.
Key competencies and Skills:
- Degree in Pharmaceutical Science from Argentinean University
- Experiencia in Regulatory strategy within a CFT
- Experience in MoH interactions
- Significant experience of regulatory drug development.
- Experience as Techincal Director.
- Proven successful leadership and project management experience.
- Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
- Excellent strategic influencing and negotiation.
- Develops collaborative working relationships.
- Fluent English.
Saavedra, Buenos Aires – Capital Federal.
