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
- 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
- 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
- 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
Before you complete this form
Please download and complete the Waymade job application form using the link below. The completed application must then be attached to this form.
Download the Waymade job application form