Regulatory Affairs Director
This role is responsible for providing consultancy support to Arriello Clients across key technical areas including clinical development, regulatory strategy and Marketing Authorisation. The desired candidate will have previous experience with development of global regulatory strategies (EMA centralised procedure experience required) including Scientific Advice, PIP and ODD for all product types and specific expertise with biotechnology and advanced therapy products is preferred.
This role is involved in the development and promotion of regulatory affairs services to existing and potential clients across the life sciences industry.
Reporting to the VP, this role supports the definition and execution of the internal Arriello regulatory affairs consultancy strategy and leads service activities within the regulatory affairs department and across the Arriello technical teams.
What will be your key responsibilities:
General
- The Regulatory Affairs Director works cross-functionally and in collaboration with key internal stakeholders such as Business Development, Marketing, Pricing and Proposals, Pharmacovigilance, Quality and Compliance, HR, legal and finance to support the Arriello business strategy.
- Operates as a Subject Matter Expert (SME) in key regulatory service areas to provide strategic and operational support to Arriello clients.
- Supports service delivery innovation through development of new ways of working or implementation of technology.
- Develops, maintains, and improves the regulatory department systems and procedures.
- Attendance at and support of, industry events such as conferences and Client meetings for the development of new Regulatory Affairs opportunities and growth of the project pipeline.
- Effectively manage and build working relationships with all stakeholders, based on transparency, trust and clear communication.
People Management
- Manage the performance of direct reports in the Regulatory Affairs team through performance of regular performance evaluation with the Regulatory Affairs team members.
- Support the Regulatory Affairs team members in their career development through coaching, mentoring, provision of opportunities to increase their expertise and by providing feedback to support this development.
Service Delivery
- Provide technical support to the commercial teams in the scoping of opportunities, identification of solutions based on the Client’s needs, development of project budgets and assembly of project teams with the appropriate expertise based on the project requirements.
- Provide solutions for complex regulatory issues to support Client goals and requirements.
- Provide technical leadership of assigned Client projects ensuring that technical deliverables are achieved, and client satisfaction is maximised.
- Provide oversight of PM activities to ensure all projects are managed according to agreed procedures, timelines and budgets, relevant hours are billed, and pricing agreements are maintained.
- Collaborate with the VP of Regulatory Affairs in the definition and execution of the commercial and service delivery strategy for the Regulatory Affairs department.
- Ensure the standards of quality in client project delivery are upheld and in compliance with ISO9001:2015 accreditation.
- Liaise with international regulatory agencies as required.
- Provision of peer review of all documents prior to submission or transfer to authorities/clients to ensure right first time and maintenance of Arriello quality standards.
- Active participation in identification and assessment of changes in legislation that will impact Arriello clients, providing proactive and practical advice for implementation or response to these changes.
Business Development and Marketing
- Collaborate with the Marketing department to ensure content is provided in support of the Arriello commercial strategy throughout the calendar year and in alignment with the defined regulatory services offered to Clients.
- Recognize upselling and cross selling opportunities during the delivery of Client’s projects.
- Demonstrate business development and presentation capabilities during bid defence, client meetings and presentations.
- Support with the development of the Regulatory Affairs project pipeline.
What experience should you have:
MINIMUM QUALIFICATIONS:
- Minimum BSc. in a scientific discipline or equivalent.
- +10 years’ experience in Regulatory Affairs and excellent knowledge of regulatory legislation across several territories including US and EU and in particular, experience with EMA centralised procedure, US BLA and NDA.
- Expert knowledge in the development of regulatory strategy, for all types of registrations.
- Experience with innovative biotechnology medicinal products including biologics, ATMPs/CGTs.
- Competent in assessment and provision of innovative solutions for complex regulatory issues.
- Excellent project management skills.
- Analytical skills; strong attention to detail
- Strategic planning skills.
- Capable of managing multiple projects and complex timelines.
- Ability to work independently and on own initiative.
- Creates a working environment that supports diversity and inclusion while working in a multi-cultural environment.
- Client focused.
- Leads by example.
What do you get in return:
- Remote working (Use of our offices in various locations, co-sharing work space or remote options available)
- 5 weeks holiday plus national holidays in your given location
- 3 personal days
- Flexible benefits, based on location
- Home office stipend
- Annual bonus program
- Other employee Bonuses (spot bonuses and employee nominated bonuses)
