Senior Regulatory Affairs Manager (remote-based)

Hobson Prior are looking for a Senior Regulatory Affairs Manager to join a fantastic pharmaceuticals industry on a contract basis with the ability to be located anywhere in the EU as the role is remotely based; excluding the UK. Our client is focused on bringing improved health and happier futures to people worldwide.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Under the supervision from a senior team member and/or Line Manager defines, develops and sometimes leads regional strategies to maximize regulatory approvals and patient access to meaningful medicines in alignment with program objectives.
• Successfully communicate objective assessments of the likelihood of success of these regulatory strategies.
• Offer regional strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs, while maintaining full compliance with applicable regulatory requirements.
• Guarantees regional regulatory strategies are written, reviewed and executed according to plan
• Alongside the line manager, you will 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.
• Manage, plan, and execute regional regulatory submissions within the area of responsibility and ensures timely approvals throughout product development and lifecycle.
• Work alongside the regional 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 Global and Regional counterparts and Integrated Franchise Team (IFT) to ensure the regional regulatory strategy is created and executed upon for all projects within area of responsibility.
• Identifies relevant regional 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.
• Monitors and informs on emerging trends, regulations and changes, with emphasis on those related to area and region of responsibility.
• May be called upon to provide direction to senior leadership, as relevant.
• Any other assigned duties.

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
• Generally strong in working well with others, within global teams and communicating with senior leadership.
• Proactively recognises regulatory issues; suggest creative solutions and strategies, including risk mitigation strategies.

Requirements:

• Required to have a BSc in an advanced scientific related degree preferred; a BA is accepted based on experience; however, an advanced degree is preferred.
• At least 5 years of regulatory experience.
• Substantial experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases.
• Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU.
• Understand and interpret complex scientific issues across projects and therapeutic area(s) of responsibility as it relates to regulatory requirements and strategy.
• Ideally, you will have experience in managing multiple filings; or managing multiple programs in closely related development area; knowledge in the EU region (as relevant to role) with global involvement is also preferred.
• Able to understand broad concepts within regulatory affairs and implications across the organisation and globally.
• Take a stand on important issues in productive, respectful way.
• 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 then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.