Manager, Regulatory Strategy, International
vor 1 Woche
The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is expanding its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines.
As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
Moderna is seeking a forward-thinking and agile Manager, Regulatory Strategy, International, based in Basel, Switzerland, to provide vital regulatory support in the dynamic field of messenger RNA therapeutics.
This role reports to the Senior Director, Regulatory Affairs Strategy, Infectious Disease, and plays a key role in interfacing with Health Agencies in EU and International markets.
Within 3 Months you will...
Begin collaborating with the Senior Director, Project teams, RA International team, and International Reg-CMC to develop and execute regulatory strategy.
Identify and assess regulatory risks for assigned projects, maintaining communication with relevant regulatory agencies.
Within 12 Months you will
Be responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.
Ensure tracking, follow-up, and archiving of correspondence, regulatory commitments, and queries from International Health Agencies.
Here's What You'll Bring to the Table:
Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory strategy
Strong knowledge of current EU and International regulations related to the clinical, nonclinical, and CMC development
Strong experience with CTD format and content regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and International countries
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
Ability to work independently to manage multiple projects in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be
-
Manager, Regulatory Strategy
vor 1 Woche
Basel, Basel-Stadt, Schweiz Moderna Therapeutics VollzeitThe Role:The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges...
-
Manager, Regional Regulatory Strategy
vor 1 Woche
Basel, Basel-Stadt, Schweiz Moderna Therapeutics VollzeitThe Role:The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges...
-
Manager, Regulatory Affairs, International
vor 1 Woche
Basel, Basel-Stadt, Schweiz Sobi VollzeitSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Manager, Regulatory Affairs,...
-
Basel, Basel-Stadt, Schweiz Moderna Therapeutics VollzeitThe Role:The Director, Regional Regulatory Strategist - ID will have the opportunity to lead the regulatory strategy with the European Medicines Agency (EMA), act as the regulatory strategy partner for International countries, and provide regulatory support to the VP, Regulatory Affairs International. This is a new role intended for a forwardlooking,...
-
Regulatory Affairs Associate Cmc Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Source Group International VollzeitPosted: Today Location: Basel, Switzerland Job Ref: BH Job Type: Contract Salary:CHF40 CHF44 per hourExpiry date: 1/18/2023 Contact:Audwin CheungXplore Life Sciences are recruiting for an Associate Regulatory Affairs CMC Manager to work for a Global Leader in Pharmaceuticals based in Basel.This is an 18 Month freelance contract and you must have valid right...
-
Regulatory Affairs Manager 100%
vor 1 Woche
Basel, Basel-Stadt, Schweiz Global Personal Partner VollzeitEINFÜHRUNG:Our profession and our passion are "HR Management".Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland.For our client, an international technology company in Basel, we are looking for...
-
Global Program Regulatory Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Novartis Vollzeit394918BRGlobal Program Regulatory Manager (GPRM - Cardiometabolic):SwitzerlandAbout the role26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitThe Life Science Career NetworkOur client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading...
-
Regulatory Affairs Manager 100%
vor 1 Woche
Basel, Basel-Stadt, Schweiz nemensis ag VollzeitFor our client, an international pharmaceutical company in Zurich, we are in search for a Senior Regulatory CMC Manager (f/m/d).Responsibilities: Prepare CMC responses to health authority questions during development, registration and product lifecycle Identify the required documentation for global submissions and negotiate the delivery of approved technical...
-
Basel, Basel-Stadt, Schweiz Moderna VollzeitThe Role:Here's What You'll Do:Develop and contribute to content, format and accountability for regulatory submissions and related supplements and amendments, including EMA regulatory documents such as meeting requests, briefing books, orphan drug designations, DSURs, MAA etc.)Work with the International local regulatory leads in Canada, Asia, Latin America...
-
Regulatory Affairs Cmc Associate Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz SimplyVision GmbH VollzeitFor our customer located in Basel/Switzerland we are currently looking for a:Regulatory Affairs CMC Associate Manager (M/F/x)**- pay rate range - given by our client: 51 chf/h*Hiring Manager Job Description: As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory documentation for our...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Pharma-Jobs24 VollzeitSie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschrittbruederlinpartner bringt als spezialisierter Personaldienstleister jeden Tag Fach- und Führungskräfte mit nationalen und internationalen Unternehmen...
-
Manager, Global Regulatory Science
vor 1 Woche
Basel, Basel-Stadt, Schweiz Moderna VollzeitThe Role:Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...
-
Global Regulatory Affairs Director
vor 1 Woche
Basel, Basel-Stadt, Schweiz Coopers Group AG VollzeitGlobal Regulatory Affairs DirectorWe are looking for a person who will develop/lead/implement regulatory strategy through a global regulatory team approach for assigned projects or product(s) across all phases of product development, and ensure timely development of regulatory strategy and operating plans.Responsibilities Participate in or lead departmental...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz ProClinical VollzeitSalary:Highly CompetitiveJob type:PermanentDiscipline:Project ManagerLocation:Switzerland- Basel, Schweiz Posting date: 27 Feb 2024Reference:57992Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or...
-
Manager, Global Regulatory Science
vor 1 Woche
Basel, Basel-Stadt, Schweiz Moderna VollzeitThe Role:Provide effective operational and regulatory support for assigned regulatory submission and maintenance activities, including preparation and submission of regulatory dossiers, and maintenance of regulatory databases and archives.Here's What You'll Do:Oversees the regulatory submission of CTAs to national HAs world-wide as required: e,g, guides and...
-
Regulatory Affairs Cmc Associate Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Manpower Suisse VollzeitFor our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.Contract duration: 18 months with extension possibleWorkload:100%Location: Basel cityDescription:As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high-quality CMC (Chemistry,...
-
Regulatory Affairs Cmc Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz SimplyVision GmbH VollzeitFor our customer located in Basel/Switzerland we are currently looking for a: Regulatory Affairs CMC Manager (M/F/x)Tasks & Responsibilities / Must Haves Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health...
-
Regulatory Affiars Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Pharma-Jobs24 VollzeitWould you like to specifically demonstrate your expertise in the field of pharmaceutical services in a new professional challenge in order to fully exploit your potential? Then take the next step with us As a specialised personnel service provider, the bruederlinpartner group brings specialists and managers in the field of pharmaceuticals, research and...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz BÜHLMANN Laboratories AG Vollzeit**BÜHLMANN Laboratories AG **ist eine international tätige und innovative Produktions- und Handelsfirma im Bereich Life Sciences. Das Unternehmen mit Hauptsitz inSchönenbuch beschäftigt mehr als 120 Mitarbeitende und ist global aktiv.Die selbst entwickelten und hergestellten diagnostischen Kits und Reagenzien werdenweltweit als **in vitro Diagnostika...
