Location(s): Switzerland

Level of position: Senior Manager

Position type: (office-based, in alignment with BlueFlex model*/field-based/)

Reporting Line: International GRS Lead

How will your role help us transform hope into reality?

Reporting to the International Regulatory Affairs Lead, the position will provide essential support in the planning and coordination of regulatory submissions as we continue for product launch(s) across our International business. The individual will also ensure effective communication and constructive working relationships with internal cross-functional stakeholders and external collaborators.

What will you do?

• Support the Regulatory Affairs International Lead in the timely planning and coordination of regulatory submissions for the UK initially, with support expected to extend to the EU and other International markets.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions for assigned projects.
• Manage and coordinate the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for registration of products in the UK, supporting for Europe, and International markets, as needed.
• Work to prepare national MAAs and lifecycle management submissions for the UK, serve as liaison between distribution partners and Blueprint cross-functional team.
• Support national-level RA activities in the EU member states in collaboration with the local RA vendors, as needed.
• Support cross functional team with local launch readiness deliverables.
• Ensure regulatory submissions are maintained in appropriate Blueprint Medicines systems in compliance with regulatory requirements.
• Support the preparation of meeting requests and briefing documents for health authority meetings, as needed.
• Lead labeling/artwork management: preparation, updating, archiving of artworks in collaboration with local RA vendors and supply chain/quality.
• Monitor the development of new regulatory requirements or guidance documents with regards to the UK, as well as EU and International countries (as needed) and advise product teams of the impact on the business or development programs.

What minimum qualifications do we require?

• Bachelor's degree; advanced scientific related degree a plus
• A minimum of 3-5 years of regulatory drug development experience and a minimum of 2 years of direct regulatory affairs experience
• Pharmaceutical industry experience essential
• Experience in oncology/rare diseases drug development a plus
• Solid working knowledge of drug development process and post-marketing regulatory requirements for the UK and EU required; knowledge of non-EU markets a plus.

What additional qualifications will make you a stronger candidate?

• Able to work well with others and communicate with senior leadership
• Strong oral and written communication skills, and negotiation skills
• Willing to set and drive aggressive project timelines
• Capable of strategic thinking and proposing innovative solutions to regulatory problems
• Must be proficient in Microsoft WORD, Project, PowerPoint, and Adobe Acrobat
• At home in a results-driven, highly accountable environment where you can make a clear impact
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
• Fluency in English and at least one other European language.
• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.

• Blueflex is our operating model which optimizes culture, productivity, & flexibility by maximizing the critical strengths of in-person work with the benefits of added flexibility. Blueflex allows for mix of in-office and remote work, enables flexibility to meet individual and business needs and makes effective use of our facilities and resources. It is a culture enhancer.

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