Regulatory Affairs Associate Director
A leading pharmaceutical client is searching for a Regulatory Affairs Associate Director to join their team in Hertfordshire. ProClinical is recruiting for this company, which specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.
In this role, the Regulatory Affairs Associate Director will be involving in leading European regulatory activities for a compound in Phase 3 development, as part of the company pipeline. This pipeline includes two compounds currently aiming for a disease modification claim. Opportunities to contribute to innovative global regulatory strategies will be available as well as opportunities for involvement in US regulatory activities.
The appointed Regulatory Affairs Associate Director will also be the EU Regulatory Lead for an early phase compound, where will input to global regulatory strategy, and the design of clinical development programmes, will be an important part of the role.
Close working with US based Global Regulatory leads and cross-functional Project Teams in the UK, US and Japan will be required.
- Setting objectives, delivering results, and implementing policies and operational targets.
- Interacting with and understanding policy changes or recommendations.
- Executing work procedures in a project context, whilst consistently exercising judgement and discretion within generally defined procedures.
- Presenting concepts, facts, and reports to mid-level internal and external clients to advise over any key trends and issues.
- Contacting clients and external vendors to troubleshoot routine client inquiries. Representing the organisation as a prime contact for technical matters of significant complexity.
- Directing the activity of a work team project, along with taking responsibility for the management of highly skilled professional employees.
- Developing and implementing regulatory strategy for the local functional area and region.
- Leading issue resolution of regulatory risks by identifying, escalating and monitoring issues.
- Organising resources and processes across multiple teams/functions to develop and deliver complete regulatory submissions within agreed timeframes.
- Providing regulatory support to project teams for allocated projects.
- Contributing to the planning, execution and assessment of product life cycle management activities and strategies.
- Contributing to, and implementing, strategy for interactions and negotiations with health authorities.
- Autonomously handling routine communications with regulatory authorities.
- Enhancing the capabilities of current resources (tools, systems, vendors, etc), technologies, and processes for the team.
- Managing contractors and ensuring that contractors, consultants and vendors complete assigned work according to agreed timelines.
- Resolving expense issues and managing costs of work teams before issues arise.
- Managing team finances in compliance with financial standards and guidelines.
- Assisting the review of 3rd arty (contractors, consultants and vendors), work products and deliverables to recommend approval of invoice payments and issue escalation where appropriate.
- Providing feedback, setting clear tasks and objectives, and coaching team members on a periodic basis.
- Providing input into recruitment, selection, performance, succession and transition activities.
- Training team members on processes and/or systems.
- Managing individual contributors, along with all employee-related activities throughout the year, including performance management and development; Identifying and communication the skills, behaviours and experiences required to develop employees.
- Setting goals, reviewing performances and providing feedback on a regular basis.
- Assisting or leading training of junior staff.
- Complying with all applicable laws/regulations of each country where the company does business.
Skills and Requirements:
- A BSc/MSc in a relevant scientific field.
- Extensive experience in regulatory methods and processes in an industry setting a necessity.
- Strong experience with EU regulatory processes and environment a necessity. This includes clinical trials, scientific advice, PIPs and orphan drugs.
- Demonstrably experience with liaising and negotiating with regulatory authorities, both verbally and in writing.
- Some experience in neuroscientific therapy desirable.
- Proficiency with MS Office (Excel, Outlook, Word) and internet functions.
- Demonstrable communication, organisational, project management, problem solving, and multi-tasking skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Roberto Esposito on +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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