Regulatory Affairs Consultant – projects in clinical development, at MAA filing stage and post-app

Mosaic Regulatory Solutions
*Job Title:* Regulatory Consultant

*Reporting to:* Team Leader / Director

*Description:*

The Regulatory consultant will be responsible for managing a portfolio of projects for a number of clients. This will encompass projects in clinical development, at MAA filing stage and post-approval lifecycle management.

*Responsibilities:*

*Expert:*

* Support regulatory projects on behalf of the client including supervised liaison and negotiation with regulatory authorities.

*Competent / Expert:*

* Take responsibility for Company activities e.g. team building sessions, as requested.

* Support regulatory procedures at both the national and EU level. Support US projects.

* Prepare regulatory submissions including clinical trial applications and amendments, MAA dossiers and variations. Assist with preparation of scientific advice requests and PIPs and Orphan drug applications

* Prepare regulatory submissions and agency interactions.

*Competent:*

* Provide support for business development activities.

* Lead regulatory projects on behalf of the client including direct liaison and negotiation with regulatory authorities.

* Manage regulatory procedures at both the national and EU level. Support US projects.

* Manage US projects

* Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects

* Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business.

* Manage regulatory submissions and interactions.

* Give input to regulatory plans to meet project and client goals.

* Ensure relevant policies and procedures are in place and adhered to in order to meet the Company’s legal responsibilities

*Competent / Developing:*

* Manage a team of regulatory professionals including supporting professional and personal development, setting and reviewing objectives and providing input and advice as needed.

* Oversee preparation of regulatory submissions including clinical trial applications and amendments, scientific advice requests, PIPs, Orphan drug applications, MAA dossiers and variations.

* Develop regulatory plans to meet project and client goals

* Generate business from new clients and foster relationships with existing clients

*Leadership:*

*Competent / Executive:*

* Tailoring management style to the individual

* Keeping people focused on goals and objectives

* Motivating individuals to perform and succeed and move forward

* Embodying the ethos of comapny and communicating the strategy and values

* Promoting a positive working environment

*Coaching and Mentoring:*

*Competent / Expert:*

* Being a role model

*Competent:*

* Sharing technical knowledge and soft skills with others

* Developing / Competent:

* Giving constructive feedback

* Spotting and nurturing potential

*Business Acumen*

*Competent / Expert:*

* Understanding our consultancy business model and contributing to the business development process when required

* Develop and maintain relationships with clients to sustain/grow the business

* Actively promoting the company through positive actions deeds and words

* Discovering and understanding client needs thereby delivering a tailored service

*Developing / Competent:*

* Actively generating business from new and existing clients

*Project Management:*

*Competent:*

* Taking responsibility for the oversight and completion of tasks within a project

* Setting appropriate milestones and monitoring progress to deliver within set parameters

* Identifying and resolving issues proactively

* Prioritising and implementing strategies to align to the client business need

*Developing / Competent:*

* Managing resource effectively

*Technical Competence:*

*Expert:*

* Attention to detail; able to work accurately

*Competent / Expert:*

* Possess working knowledge of scientific and regulatory environment

* Strong analytical skills; able to review large data sets and identify errors, inconsistencies and missing information

* Ability to analyse environment and take decisions accordingly in a timely manner

*Competent:*

* Analyse and understand current and future regulatory environment and its impact on assigned projects and apply to the business environment.

* Apply regulatory and scientific knowledge to determine solutions and solve complex problems

* Develop clear, effective and creative regulatory strategies

*Teamwork:*

*Expert:*

* Accountability for individual part of the project

* Ability to work cooperatively with others in order to achieve overall goals

* Receptive to ideas, feedback and contributions

* Commitment to deliver client and company requirements by demonstrating a willingness to help others outside the individual responsibilities

* Sharing knowledge and keeping stakeholders up to date with current project status

*Communication and Negotiation Skills:*

*Expert:*

* Foster good interpersonal relationships.

* Build trust and respect with peers and clients through good communication.

* Ability to clearly and confidently explain complex scientific issues both verbally and in writing

*Competent:*

* Influence individuals or groups to reach consensus and achieve objectives.

*Qualifications:*

* Life Science or Pharmacy Degree

* Full UK driving licence

* Qualified to work in UK

* Fluent in English

* More than five years experience in EU regulatory affairs