Senior Regulatory Affairs Manager - Great consultancy - Homeworking

Senior Regulatory Affairs manager

Location: Oxfordshire

Salary- On application

Position Summary

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

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

The SRAM 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
Project Activities

·      Manages several 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.

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

Company Development Activities

·      Assume line management supervision and mentoring responsibilities to junior employees within  as necessary.

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

·       Provides proactive input to improving  processes and promoting effective change.

Business Development Activities

·      Prepares 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.

·      Negotiates 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

·      Identifies and promotes opportunities for generating new business with existing clients and feeds back information on potential new customers.

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 without supervision.

·      Maintains confidentiality of patient and client data.

Education and Experience

·         A minimum of 5 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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