Senior Manager Regulatory Affairs International

vor 20 Stunden

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.

#LI-Hybrid

#LI-NJ1

#J-18808-Ljbffr

  • Regulatory Affairs Manager

    vor 2 Wochen

    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...

  • Executive Director, Regulatory Affairs

    Vor 4 Tagen

    Zug, Schweiz Mirati Therapeutics Inc Vollzeit

    **Job Description Summary** Reporting to the SVP and Head of International, based in Zug, and the VP Regulatory Affairs & Quality, based in San Diego, this professional will be part of both the International Leadership and the Global Regulatory Affairs Teams with responsibility for oversight of EU and International Regulatory activities to support corporate...

  • Senior Manager, International Medical Affairs

    vor 21 Stunden

    Zug, Schweiz Deciphera Pharmaceuticals, Inc Vollzeit

    Senior Manager, International Medical AffairsFull-timeDeciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a...

  • Regulatory Affairs Manager

    vor 4 Monaten

    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 2 Wochen

    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...

  • Regulatory Affairs Manager

    Vor 5 Tagen

    Zug, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager (LSW) - RZ for a pharmaceutical establishment. This role is on a contract basis and is located in Zug with hybrid working available. The client is focused on supplying novel solutions for various illnesses. **Responsibilities**: - Accountable for upkeep of product technical files and for current...

  • Associate Manager, Regulatory Affairs

    vor 2 Wochen

    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: -...

  • Senior Manager, International Medical Affairs

    vor 2 Monaten

    Oberwil b. Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    Company DescriptionDeciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative...

  • Regulatory Affairs Manager/ivd

    Vor 7 Tagen

    Zug, Schweiz Talentor Sweden AB Vollzeit

    In this role you will manage activities associated with regulatory approval of** in vitro diagnostic medical device**s. You will be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Additionally, you are responsible for assessment of device changes for regulatory...

  • Regulatory Affairs Manager

    vor 2 Wochen

    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...

  • Head of Regulatory Affairs Europe

    vor 2 Wochen

    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...

  • Global Regulatory Affairs Manager, Vaccines

    vor 2 Monaten

    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...

  • Manager Regulatory Affairs Central Europe

    vor 7 Monaten

    Zug, Schweiz Abbott Laboratories Vollzeit

    **Abbott** **is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160...

  • Regulatory Affairs Manager

    vor 2 Wochen

    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 Monaten

    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...

  • International Medical Affairs Manager

    Vor 3 Tagen

    Zug, Schweiz ITech Consult Vollzeit

    **International Medical Affairs Manager - medical affairs, clinical development or medical (scientific)** **communications, infectious diseases** **Role**: For our client in the Pharma industry based in Rotkreuz we are looking for a International Medical Affairs Manager. Roche Diagnostic Solutions provides products for use in commercial and hospital...

  • International Medical Affairs Leader

    vor 1 Monat

    Oberwil b. Zug, Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    About Deciphera Pharmaceuticals">Deciphera is a biopharmaceutical company focused on developing innovative medicines to improve the lives of people with cancer. Our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology enable us to develop a broad portfolio of groundbreaking treatments.We are leveraging our drug discovery...

  • Ra Manager

    vor 1 Woche

    Zug, Schweiz BioTalent Vollzeit

    BioTalent are partnered with an exciting company to assist their search for a newly created Regulatory Affairs Project Manager on a permanent basis as part of their ongoing growth plans. **Key Responsibilities**: Maintain the approved dossiers of the lifecycle of the products Ensure that Regulatory procedures and records with respect to CMC / Quality are...

  • Regulatory Advertising and Promotion Lead

    vor 7 Monaten

    Zug, Schweiz Apellis Pharmaceuticals Vollzeit

    **Title: Associate Director, International Advertising and Promotion Regulatory Affairs** **Location: Zug or remote (Europe)** **Reporting: Senior Director, International Regulatory Affairs** **Description**: - The Associate Director of International Advertising and Promotion (A&P) serves as an internal expert on industry codes and guidance and...

  • Regulatory Affairs Manager

    vor 7 Monaten

    Zug, Schweiz Viatris Vollzeit

    Meda Pharmaceuticals Switzerland GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted...