Opening date 21 Aug 2019
Closing date 2 November 2019

We are looking for a Head of Product Development to manage and direct Waymade’s new generic product development. Reporting to our Product Development Director you will be working alongside a part time product development consultant and manage a growing team of high calibre staff based in India and the UK.

KEY TASKS AND RESPONSIBILITIES

  • To assume responsibility for the delivery of all new product development from inception to approval.
  • Provides input to submissions for project timelines and deliverables to ensure project milestones and goals are met.
  • To contribute to recruitment, reorganisation and capex investment decisions as appropriate.
  • To oversee expenditure and ensure budgetary constraints are adhered to throughout the development process.
  • To provide scientific expertise in all stage of the product development process.
  • Ensure all team members are suitably trained and developed to perform their job roles.
  • To provide high calibre, relevant scientific opinion and recommendations in meetings and phone conference with new and existing stakeholders.
  • To reviews and approve, project plans, protocols and reports.
  • Ensures that systems are in place such that regulatory submissions and Marketing Authorisations are complete, technically accurate and comply with relevant guidelines.
  • Manages the compilation of dossiers for internal review and submission (publishing MAA’s, MA Variations, PSURs, Renewals) for ‘in line’ products.
  • Provides guidance to cross-functional teams on the structure of regional dossiers.
  • Ensures efficient preparation, despatch and tracking of electronic and paper media for ‘in line’ products.
  • Tracks progress of regional/submissions goals/milestones, identifies issues, and develops corrective action plans for ‘in line’ products.
  • Recommends and develops operational process improvements.
  • Other duties as assigned

PERFORMANCE STANDARDS

  • Maintain professional standards at all times
  • Be punctual, maintain dress standards, be polite and courteous to internal and external customers at all times
  • Act in an efficient and professional manner at all times
  • Be approachable, helpful and flexible in attitude at all

Qualifications:

  • High degree in Chemistry, Pharmacy or allied subject

Experience and Competences:

  • Experience in product development or equivalent in the Pharmaceuticals industry.
  • Thorough understanding of the Regulatory and Quality Operations area, including process and technology solutions
  • Previously worked in an EU Regulatory Authority
  • Previously worked in Manufacturing, QC, QA or Regulatory Compliance
  • Project Management
  • All round experience in regulatory procedures

Knowledge and Skills

  • Ability to communicate effectively with teams and clients
  • Attention to detail and process driven
  • Able to maintain focus whist managing multiple projects
  • Delegate and allocate responsibilities efficiently to manage projects end to end

Personal qualities:

  • Good documentation, presentation and communication skills, both written and oral
  • A self-starter with proven problem solving ability
  • The ability to work as part of a team and to develop strong alliances/partnerships both internally and externally
  • Good influencing/negotiating skills
  • Willingness to work in a collaborative and facilitative manner and travel nationally and internationally

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