Senior Manager Regulatory Affairs International Temporary Worker Position
Senior Manager Regulatory Affairs International Temporary Worker Position
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Location(s):Switzerland
Level of position: Senior Manager
Position type: (officebased in alignment with BlueFlex model*/fieldbased/
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 crossfunctional 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 UKsupporting 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 Blueprintcrossfunctional team.
- Support nationallevel RA activities in the EU member states in collaboration with the local RA vendors as needed.
- Support crossfunctional 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
- Bachelors degree; advanced scientific related degree a plus
- A minimum of 35 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 postmarketing regulatory requirements for the UK and EU required; knowledge of nonEU 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 resultsdriven 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 detailoriented a selfstarter and be comfortable with broad responsibilities in an entrepreneurial fastpaced 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 lifechanging 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 inperson work with the benefits of added flexibility. Blueflex allows for mix of inoffice 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.
#LIHybrid
#LINJ1
Required Experience:
Senior Manager
Employment Type
Intern
