R&D responsibilities: Post holder will be responsible for all aspects of medicinal product research and development from formulation concept to a finished/marketed product
This position is responsible for overseeing the entire medicine/product development cycle including selection of API and excipients, formulation development and optimisation, pilot phase and scale up manufacture design, analytical method development, container closure selection and testing, stability and or sterility analysis (where applicable) culminating in approvable regulatory submissions in-order to obtain marketing authorisations.
Regulatory Affairs responsibilities: The post holder is responsible for compliance with the applicable medicines regulatory framework covering the operations
This includes compliance with the requirements for manufacturing authorisations (including licensed medicines, specials and IMPs), marketing authorisations, a wholesaler dealer license, home office licensing and any additional legal frameworks, which may impact activity.
Submission of all new marketing authorisation applications (MAA’s)
The post holder provides regulatory advice to Senior Management Team (SMT) and Board.
The post holder is responsible for the implementation of the Pharmacovigilance local service, and for liaison with the external Pharmacovigilance QP to ensure that all required Pharmacovigilance systems are in place.
Skills and requirements
10+ years’ experience in industry as a regulatory and formulation development professional managing the pre-development to regulatory approval of medicinal products
In-depth knowledge of medicine development strategies and the drug development process and relevant regulatory requirements as related to pharmaceutical formulations
Highly experienced in all phases of pharmaceutical development and experience in launching products globally
Knowledge of pharmaceutical R&D, manufacturing, clinical trials, and contract research
Evidence of previously successfully having submitted and obtained marketing authorisations for medicines
Proven background in research and development with evidence of leading R&D functions and managing development staff
Evidence of delivering product development target
Experienced in writing and submitting pharmaceutical sections of MA applications
Experience of responding to requests for information from regulators
Evidence of staff and operational management skills
Experience of managing financial resources / budgets
Evidence of success in project management and expertise in monitoring business performance
Project / change management skills Business planning skills
Highly experienced in manufacturing as well as technical transfers to commercial manufacturing
Experience in all phases of regulatory submissions and interactions with UK and international regulatory authorities on pharmaceutical related topics both pre- and post-commercial launch
Demonstrable high performing senior management leadership experience in the formulation development function of a pharmaceutical or biotech company
Knowledge and experience of MHRA regulations
Strong abilities in strategic business operations including management of external partnerships, planning and negotiating
Strong aptitude to think strategically with excellent analytical, communication, presentation, and writing skills
A strong sense of initiative, urgency, drive, pragmatism and judgement – overall an ability to make things happen
Proven ability to work as a team member collaboratively with colleagues across all functions
Bachelors/PhD degree in pharmaceutical sciences, chemistry or related life science required