Hobson Prior are looking for 3 Regulatory Affairs Senior Manager to join a very patient focused worldwide biopharmaceutical organisation located in Zurich. You will collaborate to define and develop regional strategies to maximize regulatory and patient access success to enable patient access to meaningful medicines in alignment with program objectives.

Job Responsibilities:

• Helps to Lead the regulatory working team globally or for own region and represents as needed at project team and ensures global and/or regional regulatory lifecycle management strategy and submission planning written and executed according to plan - or oversees if delegated to vendor.
• Work with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
• For the projects/products of responsibility, collaborates with Global and Regional colleagues for the authoring of global regulatory strategies and ensures own critical deliverables as agreed within the global regulatory strategy and planning.
• Responsible for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within regions of responsibility.
• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
• Identifies relevant regional regulatory requirements and provides regulatory guidance, and expertise to internal team on the assigned projects of responsibility. Authors and reviews regional regulatory strategies as well as executes day-to-day activities for projects or may delegates to vendor with oversight.
• Manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees vendor; negotiates on behalf of project team as necessary.
• Regulatory reviewer in due diligence for licensing opportunities, development and /or marketed product opportunities.
• Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve the organisations strategic goals and objectives.
• Identifies regulatory requirements and trends across areas of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas, as requested.

Key Skills:

• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
• Generally strong leader who is effective manager and is able to bring working teams together for common objectives. Able to mentor and develop skills of team members.

Requirements:

• A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 7/8 years regulatory and/or related experience.
• BSc degree or equivalent in science; advanced degree preferred.
• Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
• Solid working knowledge of regulations and guidances governing drugs and biologics in all phases of development, including post-marketing, in the US and/or EU (relevant to role).
• A good understanding of basic regulatory requirements in emerging markets preferred. Awareness of evidence requirements beyond the regulators (e.g. HTA bodies).
• Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
• Preferred experience in managing major regulatory filings; and significant contributor to regulatory and/or development strategies.
• Experience in managing personnel a plus; 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.