About this role
The Director of Regulatory Affairs is accountable for the development and performance of the Regulatory Affairs team. Delivering the business strategy, operational activities and creating value for Our clients, Clients. Accountable for Project ownership of regulatory projects for global ENDS and non-ENDS markets (e.g. EU Medicinal products, EU TPD and US PMTA and MRTP).
This is a relatively new area of expertise for Our client and the Managing Regulatory Consultant will need to have the knowledge and experience to establish and develop the department and the team, including processes and approach.
- Grow strategic relationships with key clients and regulatory agencies.
- Leading the scientific evaluation and regulatory submission strategy to ensure they are innovative, defensible and facilitate product approvals by regulatory authorities to deliver pre and post submission requirements in the UK, EU, US and ROW markets
- Demonstrating knowledge and expertise across CTD workstreams covering CMC, non-clinical and clinical.
- Providing SME knowledge and experience of medical device regulations and post marketing surveillance requirements.
- Increase efficiency, capability and performance within the team.
- Focus on collaboration to ensure all requirements for a regulatory scientific assessment are met.
- Responsible for processes that evaluate adherence to various governmental policies, regulations, standards, procedures and guidelines under which the company must operate.
- Client-facing advice on manufacturing control elements within a regulatory submission.
- Lead author on manufacturing control for regulatory dossiers including PMTA, MRTP, NDA and MAA.
- Advice clients on the need for implementation of GMP and other appropriate standards through manufacturing sites and supply chain.
- Create bespoke post-marketing surveillance programmes for clients adapted from the standards and guidelines in place for pharmacovigilance
- Help define client-specific standards where external guidelines do not exist
- Define user requirements for a regulatory information management system and manage the procurement and implementation of system within the organisation
- Act as an internal reviewer of regulatory submission narratives before submitting to clients.
- Train and mentor internal regulatory professionals to agreed training standards and initiatives.
- Perform other duties as and when required.
Qualifications and Education Requirements
Graduate of Science, Chemistry or Engineering related subject. PhD desirable.
Significant experience in Regulatory and scientific role - 8+ years minimum.
Key skills and attributes
- Ability to work effectively and efficiently both within regulated environments (e.g. GMP/ GLP) and agile R&D environments.
- Committed to advancing a smoke-free future
- Experienced People Leader / Manager
- Knowledgeable in the Framework of ENDS or Pharmaceutical industry.
- Experience in interacting with global regulatory agencies e.g. FDA, EMA
- Demonstrated business / commercial acumen
- Proven high level project management skills.
Salary and benefits
Salary £70,000 - £100,000
Day a fixed day off every 3 weeks which equates to approx.17 days leave per year.
Holidays 25 days plus stats
Annual bonus 10% salary based on company and personal performance
Life Insurance 2 x Death in Service
Health Care Sovereign Health Cash Plan
Long term sick insurance