Senior Manager Regulatory Affairs International

vor 2 Wochen

Zug, Schweiz Blueprint Medicines Vollzeit

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.

#J-18808-Ljbffr

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Zug, Schweiz Bioeq AG Vollzeit

    About Bioeq Bioeq AG is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon and is based in Zug. We license, develop and commercialise a biosimilar, which is a successor product of Lucentis® (ranibizumab), a successful branded biopharmaceutical. We are a young and dynamic company, supported by an international network of...

  • Senior Manager Regulatory Affairs Europe

    Vor 2 Tagen

    Zug, Schweiz Cytokinetics Vollzeit

    Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...

  • Senior Manager Regulatory Affairs Europe

    vor 1 Woche

    Zug, Schweiz Tbwa ChiatDay Inc Vollzeit

    Senior Manager Regulatory Affairs EuropeCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader...

  • Senior Manager, Regulatory Affairs CMC, Zug

    vor 1 Woche

    Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Senior Manager, Regulatory Affairs CMC, ZugClient:Location:Job Category:OtherJob Reference:c5d7e2e6e8faJob Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:DescriptionThe CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious,...

  • INTERNATIONAL REGULATORY AFFAIRS 60%

    vor 1 Woche

    Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Client:gloor & lang Pharma and Biotech RecruitingLocation:Job Category:OtherJob Reference:d756a64d20ffJob Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:Innovative Biologic submissions – early to late phaseOur client is an R&D driven biotech company based in Zurich. Own Research and development...

  • Regulatory Affairs Manager

    vor 1 Woche

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently seeking a Regulatory Affairs Manager to join our local Regulatory Affairs team located in Zug, Switzerland. This role will be working in a hybrid working model. We are looking for a highly motivated individual to join our team as a Regulatory Affairs Manager. In this position, you will play a crucial role in ensuring adherence...

  • Manager, Regulatory Affairs

    Vor 5 Tagen

    Zug, Schweiz Seagen Vollzeit

    Position Summary: The Regulatory Affairs Manager will report to and support the Regulatory Affairs Director by leading the preparation and submissions of regulatory dossiers to European and Swiss competent authorities, in line with the global regulatory plan for one or more Oncology products. Principal Responsibilities: - Provide effective regulatory and...

  • Senior Manager/Associate Director, Regulatory, International

    vor 1 Woche

    Zug, Schweiz Tbwa ChiatDay Inc Vollzeit

    Senior Manager/Associate Director, Regulatory, InternationalAbout BridgeBioBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic...

  • Senior Manager, International Medical Affairs

    vor 2 Wochen

    Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    We are searching for a highly motivated, insightful, and resourceful individual to join the Medical Affairs International team. The Senior Manager, International Medical Affairs is a highly visible and impactful role and will be instrumental in supporting and leading Medical Affairs activities for our commercial product (ripretinib) at European level and as...

  • Associate Manager, Regulatory Affairs

    Vor 3 Tagen

    Zug, Schweiz Seagen Vollzeit

    Position Summary: The Regulatory Affairs Associate Manager will report to and support the Regulatory Affairs Director/Associate Director by leading the preparation and submissions of regulatory dossiers to European and Swiss competent authorities, in line with the global regulatory plan for one or more Oncology products. Principal Responsibilities: -...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager for a biotech corporation. This role is on a contract basis with the ability to work remotely in Europe. **Responsibilities**: - Handle the relationship with the Clinical Research Organisation contracted for some clinical studies. - You will assist with different regulatory proposals to the marketing...

  • Senior Manager/Associate Director, Regulatory, International Zug, Switzerland

    vor 1 Woche

    Zug, Schweiz BridgeBio Pharma Vollzeit

    Senior Manager/Associate Director, Regulatory, InternationalBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions...

  • Regulatory Affairs Manager

    Vor 3 Tagen

    Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the...

  • Drug Regulatory Affairs Manager

    Vor 3 Tagen

    Zug, Schweiz nemensis ag Vollzeit

    At nemensis ag, we have connected thousands of applicants with their dream job and given them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Rotkreuz, we are looking for a Drug Regulatory Affairs Manager. **Job Purpose**: Takes care of all drug regulatory affairs matters regarding the...

  • Head of Regulatory Affairs Europe

    Vor 5 Tagen

    Zug, Schweiz Covis Pharma Vollzeit

    **ROLE OVERVIEW** **WHAT YOU CAN EXPECT TO DO IN THE ROLE**: Reporting to the EVP, Regulatory & Scientific Affairs, you will partner with the Head of Regulatory Countries and Head of Commercial EU & International to ensure that regulatory licenses are submitted to grow the business. You liaise, negotiate, and orchestrate meetings and teleconferences with...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Zug, Schweiz Talentor Sweden AB Vollzeit

    **Responsibilities**: - Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products. - Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of...

  • Global Regulatory Affairs Manager, Vaccines

    vor 1 Woche

    Zug, Schweiz GSK Vollzeit

    **Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53 **Posted Date**: Oct 31 2024 **Global Regulatory Affairs Manager, Vaccines Therapeutic Group**: Job purpose: As a **Global Regulatory Affairs (GRA) Manager**, you will join the GRA Vaccines Therapeutic Group in...

  • Director Regulatory Affairs

    vor 2 Wochen

    Zug, Schweiz Medison Pharma Vollzeit

    Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases. Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored-solutions...

  • Regulatory Affairs Manager

    Vor 3 Tagen

    Zug, Schweiz Coopers Group Vollzeit

    **Regulatory Affairs Manager (M/F/d)**: - Location Zug - Contract type temporary contract - Start/End: ASAP - 12 months after start date Tasks & Responsibilities - Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products. - Manages development and...

  • Manager/associate Director

    vor 2 Wochen

    Zug, Schweiz GSK Vollzeit

    **Site Name**: UK - London - New Oxford Street, Switzerland - Zug, UK - Hertfordshire - Stevenage **Posted Date**: Nov 25 2024 Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs CMC role could be an ideal opportunity to...