Hobson Prior are looking for a Regulatory Affairs Associate Director - Rare Disease to join a very patient focused worldwide biopharmaceutical organisation located in Zurich.

Job Responsibilities:

• 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.
• You will define, develop and lead regional strategies to maximize 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.
• Delivers 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.
• 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.
• 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
• Mentors team members, if required, to support scope of project work.

Key Skills:

• Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Must be strong leader that creates vision for group.

Requirements:

• A minimum of 10 years of pharmaceutical industry experience.
• A minimum of 8 years of regulatory experience or combination of 10 years regulatory and/or related experience.
• BSc. 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.
• Preferred experience in managing multiple filings; or managing multiple programs in closely related development area; expertise in either EU or US region (as relevant to role) with global involvement also preferred.
• Experience in managing personnel required; experience managing relationships with CROs and/or contractors also preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.