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Vacancy details
Vacancy description:
Job Code:
154314
Job Title:
Regulatory Affairs Specialist
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire
Min experience:
N/A
Annual salary:
Negotiable (45000 - 50000 £)
Apply by:
18 May 2008
We are currently looking for a Regulatory Affairs Specialist with a track record in CMC data interpretation to join a leading Clinical Research Organisation.
1. Education/Qualifications Required
Graduate, postgraduate, 4-year college degree, or equivalent, ideally in a scientific or
healthcare discipline.
2. Experience
Experience of regulatory affairs in either a CRO or pharmaceutical industry with some experience of strategic development experience.
Extensive experience of global clinical trials.
Ability to interpret CMC, preclinical and clinical data
Previous experience of writing key regulatory documents e.g. IMPD
Previous participation in EU regulatory submission process
3. Job Summary
Provides regulatory affairs advice and support for key company projects.
Assists with the management of regulatory affairs within the company.
Provides regulatory advice, support and documentation relating to the company business activities worldwide.
Devises and assists in delivery of regulatory affairs training across the departments.
Acts as a mentor and source of expertise to RA staff.
Supports business development activities.
Provide strategic regulatory advice on clinical development plans as required
Participation in global project teams as required
Liaising with Key Regulatory Authorities
Assists the Senior Regulatory Affairs Specialist to develop new business opportunities for the regulatory affairs department.
4. Job Duties and Responsibilities
Produces global clinical trial applications, clinical study reports, publications and summary documents.
Produces expert reports, investigator brochures, and supporting regulatory documentation.
Acts as the RAPM for designated complex projects and manages the regulatory affairs aspects of the project.
Participation in Global project Teams where necessary
Ability to provide strategic regulatory advice to clients on their proposed clinical development plan
Ability to become ”expert” in new therapeutic areas
Able to assess CMC, preclinical and clinical data for NCEs, biotechnology and other therapies
Assists in the management of projects in line with budgets and agreed timelines to achieve client satisfaction.
Sources appropriate data, information and documentation from clients and/or their nominees to fulfil regulatory requirements.
Supports regulatory affairs management in ensuring departmental awareness and compliance of current local, national, regional and harmonised guidance and requirements for the format, content and control of all types of regulatory procedures and submissions.
In conjunction with regulatory affairs Management, creates and maintains specific project tracking systems incorporating all relevant information.
Acts as a contact for and liaises with clients, project managers and other members of project teams to obtain relevant information to fulfil regulatory requirements.
Maintains a superior awareness and familiarity with the current global regulatory affairs environment.
Maintains specific project tracking systems incorporating all relevant information.
Liaises with project managers and other members of project teams to fulfil regulatory requirements.
Generates and reviews reports of regulatory data using appropriate systems.
Prioritises personal workload in line with agreed project plans.
Uses appropriate IT and software tools to ensure the correct format and presentation of documents.
Assembles, reproduces and archives (hard and electronic copies) technical documents, as appropriate for the document type.
Follows internal SOPs, specifically those relating to Technical Writing and Regulatory Affairs.
Develops and writes SOP’s.
Achieves appropriate quality standards in all documentation within the timelines dictated by project plans.
Participates in business development activities
Performs other duties as assigned by management.
Is involved in the finding of solutions to bonus, salary or promotion issues.
5. Key Competencies
Demonstrates an excellent knowledge of ICH-GCP, global regulatory guidance and relevant company SOPs.
Demonstrates ability to develop and maintain a regulatory affairs contact network.
Demonstrates a good knowledge of clinical trials methodology.
Demonstrates a working knowledge of protocols and indications being studied.
Demonstrates a working knowledge of Regulatory Guidelines and were to find these.
Demonstrates an excellent understanding of potential project related problems and resolution options.
Resolves project related problems and prioritises workload to meet deadlines with minimal support from management.
Demonstrates superior ability to collect, interpret and use regulatory data.
Demonstrates superior understanding of the role of Regulatory Affairs within the product life cycle from conception to approval.
Creates Regulatory submissions to a superior standard
Motivates other members of the project team to meet timelines and project goals.
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
Demonstrates high self-motivation, and is able to work and plan independently as well as in a team environment.
Identifies own training needs and initiates response.
Prioritises workload to meet deadlines.
Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and positive interactions with colleagues.
Demonstrates superior communication skills (written and oral).
Demonstrates excellent interpersonal skills.
Exhibits excellent knowledge of service culture and client interactions.
Exhibits excellent mentoring skills.
Provides accurate and timely administration.
Acquires and demonstrates an excellent knowledge of the company.
Possesses practical knowledge of IT tools and systems used by the company.
Demonstrates flexibility.
Is innovative and proactive.
6. Travel Required
Available for domestic and international travel including overnight stays.
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