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Trabajo : Senior Regulatory Affairs Consultant, Dublin (home based):

La descripción del trabajo.:

Trabajo :
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   » Company:
   » Location:
Ireland, Dublin
   » Salary:
negotiable / month
   » Job type:
   » Posted:
2 mins ago
   » Category:

The position offers a lot flexibility and career development opportunities to the right candidate and we are looking for a diligent and enthusiastic personality to join our growing team and open our new office in Dublin.
As Senior Regulatory Affairs Associate, you will work in our global Regulatory Affairs team, on a variety of projects. Your day-to-day activities will be client facing and will include helping our clients or partners in preparing regulatory strategies, documents and submissions, dealing with specialists, gathering regulatory intelligence, checking study documentation for legal representative clients, providing expert regulatory advice, maintaining document control and regulatory systems specific to the role of Legal Representative, and tracking of your project timelines and progress. Other tasks will involve supporting the QA manager in ensuring quality systems remain in compliance, assisting the management team with cost proposals and bid defence, and office administration as required by a small business.
* Working closely with the international team to manage assigned key client accounts
* Manages Legal Representative projects, performs assessments of study documentation for compliance with EU regulations and guidance
* Coordination, preparation, compilation and submission of CTA/IND, including core document review
* Involvement in MAA/NDA projects, Variations/Lifecycle submissions, DSUR, PSUR, Renewals, Agency briefing documentation
* Management and implementation of label reviews, translation requirements, fee requirements for regulatory submissions
* Planning, preparation and submission support for scientific advice procedures, orphan designation requests and meetings, and Paediatric Investigation Plans (PIPs)
* Regulatory writing and review of core documents for CTA (IMPD, IB, PIS/ICF, etc.) and CTD Modules
* Participates in the development and implementation of regulatory strategy for specific client programmes
* Lead on the design and execution of certain sections of regulatory submissions
* Researches and responds to client enquiries and regulatory questions
* Supports Regulatory Managers in developing and executing strategies and submission plans for client projects
* Assists the Managing Director and other team members in writing bids, contracts and other project related documents
* Coordinates and completes reports required by regulatory authorities
* Maintains & updates company quality trackers and registers and project files
* Liaises with clients, consultants and suppliers, in a professional manner, with a commitment to quality and in line with the company?s ethos
* Three years? experience in Regulatory Affairs or relevant industry area
* Bachelor?s or higher graduate degree in a science related field, or equivalent experience
* Experience preparing, submitting, and working closely with EMA, FDA and/or National Competent
* Authorities for CTA?s, ODA?s, PIPs, MAA?s and scientific advice
* Capable of strategic thinking and proposing innovative solutions to regulatory problems, with consideration to cross-functional implementation
* Knowledgeable and experienced in interpretation of regulations
* Excellent understanding of the clinical development process, GxPs, and cross-functional interactions in development
* Medical Device experience a bonus
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Categorí­a del Empleo: Otras [ Ver todos Otras  ]
Requerimientos de Idioma:
Tipo de Empleo:
Sueldo: No especificado
Titulación: Sin especificar
Experiencia: No especificado
Localización del Empleo: Ireland, Dublin, otro
Tipo de empresa Empleador
Día de envío: 2019/01/12 / Viewed 16 times
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