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

Employer
Mosaic Regulatory Solutions
Location
Home Based
Salary
Flexible
Start date
14 Sep 2022
Closing date
14 Oct 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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

Company

Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.

Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.

We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.

Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.

Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.

Company info
Website
Telephone
07951 082482
Location
Blackheath
London
SE3
GB

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