Regulatory Affairs Product Development

hace 1 semana

Madrid, Madrid, España Morgan Philips Executive Search A tiempo completo

Global responsibility:


Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations.

Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. Maintains a current knowledge of regulations and guidance documents, providing analysis to project teams.

Essential functions of the job include:
Provides regulatory guidance throughout the clinical development life cycle.


Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.

Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers.

Works within a project team, and where necessary, leads project for the region or globally.

Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs.


Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.

Assist in development of Regulatory Affairs Specialists and other operational area staff, as required.


Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information.

Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.

Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval.

Provides ICH/GCP guidance, advice and training to internal and external clients.

Competencies:


Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.

Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy.

Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied.

Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development.

Requirements and personal skills:

Education:
Bachelors Degree (preferably in Health Sciences such as Pharmacy, but also Chemistry, Biology, Biochemistry, or similar).

Languages:
Fluent in English (oral and written). Knowledge of other languages will be an asset.

Experience (years/area): min 3 years of relevant experience.

Specific Knowledge:
Basic knowledge of International Standards in terms of drug registration and drug development including ICH/GCPs and regulations/directives. Knowledge of international markets and distribution business is desirable.

Personal skills:
Initiative and proactivity, ability to make decisions autonomously, decisiveness. Meticulous and detail oriented.

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