Associate Director Rare Diseases
An internationally and leading pharmaceutical company is seeking to recruit an Associate Director Rare Diseases to their office in Switzerland. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.
- Defines, develops and leads regional strategies to maximise regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives.
- Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
- Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
- Provides regulatory expertise for multiple projects including one highly complex project within core therapeutic area, focused on non-clinical and clinical aspects of drug development and / or post-marketing compliance and life cycle management.
- Mentors team members, if required, to support scope of project work.
- May be called upon to act as deputy to the Regional therapeutic area lead and/ or Region regulatory head, attending internal leadership team meetings, as appropriate.
- Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to therapeutic areas and/ or region of responsibility enabling proactive approach and planning to future business requirements. May be called upon to provide direction to senior leadership, as relevant.
- For Europe based roles, manages and oversees interactions with EMA and national health authorities (and HTAs jointly with value and access team in context of parallel consultation) in the Europe Union and European Economic Area for all products in defined therapy area scope. Provides interpretation to the business.
- Ensure global/regional regulatory strategies are written, reviewed and executed according to plan and appropriately capture patient access requirements. Usually has own Regulatory lead role.
- Provide strategic and tactical advice and guidance to allow the timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
- Partner with the regional/LOC market access and LOC RA colleagues to define the strategy for, and to lead and oversee joint interactions with regional and national regulatory/health agency/HTA bodies on value and evidence topics and to support heath authority decision making.
- Collaborates with the company's counterparts and IBT to ensure a regional regulatory strategy is created and executed upon for all projects within area of responsibility.
- Identifies regulatory requirements and trends across scope of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- Directs and oversees multiple projects, generally has regional oversight for compounds in a minimum of one disease area.
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility.
Skills and Requirements:
- A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience.
- Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred.
- Extensive pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and post-marketing phases.
- Solid working knowledge of regulations and guidance's governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role), with a good understanding of basic regulatory requirements in emerging markets.
- Understanding of evidence requirements beyond the regulators (e.g. HTA bodies).
- Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements and strategy.
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 contact Kelechi Dyke at 0203 854 0200 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.