Director of Regulatory, Quality and Scientific Affairs
Salary: Excellent salary and executive benefits package
Our client is an entrepreneurial, innovative pharmaceutical business, who is building a pipeline of consumer self-care healthcare brands, enabling individuals to manage their health requirements and save money for the NHS.
This VC/PE backed business is led by a number of UK experts in this field and we are looking to identify a Director of Regulatory, Quality and Scientific Affairs to complement the team and be an integral part in the next exciting phase of the organisation's development.
Reporting to the CEO, your duties and responsibilities will include:
*Providing the vision and direction for the function in line with the aims, objectives and business plan. Working constructively and collaboratively to contribute to the achievement of the company's Road Map and strategic goals.
*Delivering the business plan and objectives along with the budget in line with business requirements.
*All regulatory submissions and associated regulatory intelligence for reclassification applications, clinical trial applications, marketing authorisations and maintenance and promotional/non-promotional materials.
*Ensuring all activities are undertaken in line with Regulatory Affairs requirements, the company's standard operating procedures and business objectives for assigned product(s) and/or countries.
*Complying with all the relevant Laws and Regulations that relate to the core activities.
*Leading the strategic interaction and communication with local Health Authorities and regulatory agencies and act as a point of contact.
*Working with the Head of Innovation, Brand Managers and other relevant team members to give input to the development of new products; marketing plans and sales activity.
*Leading the creation, maintenance, training, evaluation and tracking of business owned procedural documents such as policies, SOPs, manuals and working instructions that are needed to fulfil regulatory and quality obligations including but not limited to those in the scope of Good Manufacturing Practice, Good Distribution Practice, Good Pharmacovigilance Practice, and Good Clinical Practice.
*Writing the content of submission documents and expert reports (clinical, non-clinical and quality summaries, overviews and addenda) at a highly scientific and clinical level.
*Providing input to the design of clinical research studies.
To be successful in the role you will have the following skills, knowledge and experience:
*Ideally a Masters or Doctorate in a scientific, clinical or regulatory related subject with experience in medical or regulatory affairs or the healthcare field.
*Extensive experience in and understanding of the role of Regulatory Affairs, with an understanding of current trends.
*A working knowledge of reclassification along with experience of non-prescription products and regulatory requirements related to reclassification.
*Be commercially astute and capable of reading and managing a P & L.
*Experience of managing in a complex and changing environment and be able to see the bigger picture and long-term goals.
In return you will have the opportunity to be at the beginning of the journey with this exciting business venture, which is changing the market and helping people to self-manage their health issues. There will also be the opportunity to share in the growth and success of the company.
If you are an ambitious Director of Regulatory, Quality and Scientific Affairs who is interested in being a member of this top team where you will have real influence and an opportunity to share in the growth and success of the company, please can you send your CV in WORD format, quoting reference 277988/1. Please give details of your current remuneration package and availability. We regret we cannot take telephone enquiries relating to this vacancy, due to the high level of responses expected.