Regulatory Affairs Manager - Whole breadth of regulatory work- Remote working offered

Regulatory Affairs Manager

Position Summary

The Regulatory Affairs Manager (RAM)  is an experienced Regulatory Affairs professional who is able to provide strategic drug development and regulatory services to clients.

The RAM has a broad regulatory background encompassing a variety of therapeutic areas and drug technologies.  

The RAM is responsible for the overall conduct of assigned regulatory projects and is accountable for the delivery of these projects in accordance with the agreed methodology, timelines and budget.

Responsibilities

·      Manages one or more regulatory projects throughout the entire project lifecycle, within set budget, timescales and quality parameters.

·      Acts as a main point of contact for the client during the full duration of the project. Identifies and actions opportunities to increase client satisfaction and foster repeat business. Ensures accurate invoicing for all the projects under his/her direction.

·      Collaborates and liaises with other company colleagues in providing a comprehensive product development service to clients.

·      May assume line management supervision and mentoring responsibilities to junior employees within .

·      Provides strategic and/or tactical plans and advice to clients on matters concerned with their product development and regulatory approval.

·      Supports the preparation of written quotations for clients of the anticipated financial and human resources, timelines and milestones, activities and outcomes necessary to complete a project to their stated specifications.

·      Supports negotiations with clients on project contract details based on the written quoted costs of the anticipated financial and human resources, timelines and milestones, activities and outcomes necessary to complete the project to the mutually agreed specifications.

·      Participates in meetings with colleagues and clients on matters related to any current and future projects and contracts

·      Supports senior management and colleagues on matters related to generation of new business opportunities.

·      Maintains good working relationships with company colleagues at all times.

·       Contributes to improving  processes and promoting effective change.

Competencies

·      Well-developed sense of the requirements for a scientific argument.

·      Excellent written and oral communications skills; must be articulate in explanations and communicate in a clear, positive fashion with clients, management, and staff at all times.

·      Must read, write, and speak fluent English.

·      Knowledge of the rules of English grammar, paragraphing, and sentence construction in a scientific context.

·      Dedication to quality and reliability in all work tasks.

·      Responsiveness to client needs and focus on client satisfaction.

·      A genuine commitment to team work on project teams and among regional staff.

·      Self-motivation, eagerness to grow professionally, and commitment to self-development.

·      Functions independently with little or no supervision.

·      Maintains confidentiality of patient and client data.

Education and Experience

·         A minimum of 2 years of employment-related experience in regulatory affairs, dealing with regulatory authorities in Europe and/or with the FDA.

·         Experience of working with budgets.

·         Typically a minimum of three years experience using computerised information systems.

·         Experience with Microsoft Office and Adobe Acrobat.

·         Life Sciences degree, pharmacy, medical or veterinary degree, advanced degree preferred.

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