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

5 days left

Location
Home Based
Salary
Flexible
Posted
31 Aug 2021
Closes
30 Sep 2021
Ref
D98822
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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

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