Hobson Prior are looking for a Regulatory Affairs Senior Manager to join a very patient focused worldwide biopharmaceutical organisation located in Zurich.

Job Responsibilities:

• Provides regulatory expertise and strategic focus for assigned development projects and /or marketed product life cycle management.
• Responsible to deliver regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs.
• You will manage interactions with EMA and national health authorities (and HTAs in context of parallel consultation) in the Europe Union and European Economic Area for specific products.
• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to project areas and/ or region of responsibility enabling proactive approach and planning to future business requirements.
• Effectively communicates objective assessments of the likelihood of success of these regulatory strategies.
• For Europe based roles, primary EMA contact for projects/products of responsibility.
• As Regional Lead, may be called upon to act as deputy to the Global Regulatory lead, attending internal leadership team meetings, as appropriate.

Key Skills:

• Effective manager who can bring working teams together for common objectives.
• Experience managing relationships with CROs and/or contractors preferred.
• Ability to sit or stand for long periods of time while traveling.
• Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.

Requirements:

• BS degree or equivalent in science (advanced degree preferred).
• 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.
• Considerable experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
• Sound working knowledge of regulations and guidance's governing drugs and biologics in development, including post-marketing in the US and/or EU (relevant to role).
• A good understanding of basic regulatory requirements in emerging markets is a plus. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies)
• Understands and interprets complex scientific issues and capability to relate to regulatory requirements and strategy.
• Proven regulatory submissions capability in a region (Europe, US, EM).
• Able to demonstrate skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally.
• Ability to proactively identifies regulatory issues, offers creative solutions and strategies, including risk mitigation strategies.

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.