Aktuelle Jobs im Zusammenhang mit Sr. Manager, Regulatory Operations, Project - Basel - Moderna
-
Sr. Director of Regulatory Compliance
vor 3 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: The Sr. Director of Regulatory Process and Compliance position will work cross-functionally to drive activities that will ensure a state of continuous compliance at Moderna and build inspection-preparedness capabilities and sustain a positive compliance reputation between Moderna’s business partners, Health Authorities and cross-functionally...
-
Sr. Manager
vor 4 Monaten
Basel, Schweiz AWS EMEA SARL (Switzerland Branch) - G96 VollzeitBachelor's Degree in Computer Science or other related fields, or equivalent experience. 15+ years of experience in project/program management in a technical field. 10+ years of IT security audit, compliance and/or relevant regulatory experience or financial services regulatory experience (10+ years), manager experience of 8+ years We are open to hire for...
-
Manager, Regulatory Operations Emea
vor 4 Monaten
Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit**Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...
-
Manager, Regulatory Strategy
vor 4 Monaten
Basel, Schweiz Moderna Therapeutics Vollzeit**The 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...
-
Manager, Regulatory Strategy, International
vor 3 Monaten
Basel, Schweiz Moderna Vollzeit**The 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...
-
Regulatory Affairs Manager
vor 4 Monaten
Basel, Schweiz LHH VollzeitWe have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...
-
REACH Regulatory Project Manager
vor 4 Monaten
Basel, Schweiz Exponent VollzeitOur Opportunity We are currently seeking a REACH Regulatory Project Manager to operate within our Industrial Chemicals group for our Chemical Regulation and Food Safety Practice to provide leadership and support project teams working on regulatory submissions for the registration of industrial chemicals in the EU and UK. The role could be based from...
-
Project Manager, Medical Excellence and Operations
vor 4 Monaten
Basel, Schweiz BeiGene VollzeitGeneral Description: - The Project Manager (PM) Medical Excellence and Operations will support the operational needs of the Europe Regional Medical Affairs team and its systems, tools, and other operational initiatives. The project manager will support planning and execution of Medical Affairs initiatives. This includes coordinating and overseeing...
-
Sr. Manager, Supply Chain
vor 3 Monaten
Basel, Schweiz BeiGene VollzeitBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Sr. Manager, Supply...
-
Regulatory Project Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Exponent VollzeitJob SummaryWe are seeking a highly skilled Regulatory Project Manager to join our Industrial Chemicals group at Exponent. As a key member of our team, you will provide leadership and support to project teams working on regulatory submissions for the registration of industrial chemicals in the EU and UK.Key ResponsibilitiesProvide strategic advice to clients...
-
Sr. Manager, Supply Chain
vor 2 Monaten
Basel, Schweiz BeiGene VollzeitBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Sr. Manager, Supply Chain CMO...
-
Sr. Manager, Supply Chain
vor 3 Wochen
Basel, Schweiz BeiGene VollzeitBeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Sr. Manager, Supply Chain CMO...
-
Manager, Regulatory Affairs Emea
vor 3 Monaten
Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit**Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...
-
Manager, Regulatory Strategy, International
vor 3 Monaten
Basel, Schweiz Moderna Vollzeit**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...
-
Technical Regulatory Support Manager
vor 4 Monaten
Basel, Schweiz GITR Vollzeit**EINFÜHRUNG**: As a preferred supplier for Roche in Basel, we are looking for an individual as **Technical Regulatory Support Manager**: with contract for 1 year. The earliest start date is within 2 months. Home Office will be possible for max. 2 days a week. **AUFGABENBESCHREIBUNG**: - Proactively support the technical regulatory department on the...
-
Workshop Operations Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Jet Aviation AG VollzeitJob SummaryAt Jet Aviation AG, we are seeking a highly skilled Workshop Operations Manager to oversee the daily operations of our sheet metal production team. As a key member of our team, you will be responsible for ensuring the efficient and effective production of high-quality aircraft components.Main ResponsibilitiesTeam Leadership: Supervise a team of up...
-
Regulatory Affairs Manager
vor 4 Monaten
Basel, Schweiz Proclinical VollzeitProclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...
-
Senior Manager – CMC Dossier Operations Lead
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Aixial Group VollzeitSenior Manager – CMC Dossier ManagerLocation: Basel, SwitzerlandAixial Group is a CRO (Clinical Research Organization) specializing in Life Science.We provide technical support on clinical projects from phases I to IV and post-market.Our services include clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, and HEOR.We operate in...
-
Regulatory Technical Manager
vor 3 Monaten
Basel, Schweiz Proclinical VollzeitProclinical are recruiting for a Regulatory Technical Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Accountable for preparation and upkeep of CMC documentation in internal document management systems and assist with associate actions. - Handle regulatory changes throughout...
-
Global Dp Project Portfolio Manager
vor 4 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: The person in this role will be responsible for defining and actively managing the portfolio of high priority and complex projects at a strategic DP supplier in collaboration with the cross-functional plant teams (aka PODS) to successfully execute on project deliverables. Provides comprehensive project management for the site from early concept...
Sr. Manager, Regulatory Operations, Project
vor 3 Monaten
**The Role**:
**Here’s What You’ll Do**:
Use and share best practices while operating in a highly dynamic environment Lead and / or contribute to the planning, preparation (where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Coordinate the input, maintenance, and revision of project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
Support operational and compliance activities for assigned deliverables, including generating work requests, submission content plans, and submission tracking.
Support the programs on organizational process optimization (e.g Knowledge sharing).
**Here’s What You’ll Bring to the Table**:
Minimum Requirements -Education and Experience
BA/BS Degree in Science or related discipline or 5+ years relevant experience
Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
General knowledge of drug development
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams
Strong communicator and team player
Preferred Experience
Regulatory experience
Managed regulatory deliverables at the project level
Thorough knowledge of the drug development process
Comfort working in a dynamic environment
Prior experience with Veeva
Skills and Capabilities
Cultural awareness
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Proficiency with common project management (e.g., SmartSheet) and document management tools
Ability to work independently and as part of a team
Influencing and stakeholder management skills
Continuous Improvement and knowledge sharing focused
**Here’s What You’ll Do**:
Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.
Develop submission project timelines that identify key milestones to meet business objectives (e.g. from clinical trial initiation to regulatory submission and approval)
Track and monitor timelines for key activities (e.g. database lock, document deliverables, authoring responses to health authority questions and meeting regulatory commitments).
Ensure roles and responsibilities for project team members are clearly documented.
Lead submission working group cross functional meetings to drive decision making and project execution.
Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.
Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations.
Ensure overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.
Identify and recommend solutions for timeline concerns or obstacles, including risks and issues; engaging appropriate leads for mitigation and resolution, ensuring that all issues arrive at a conclusion or recommendation.
May assist in management of special projects as needed, e.g. oversight of system/process improvement projects.
**Here’s What You’ll Bring to the Table**:
BS degree in a scientific field with 8 years of experience in a biotechnology or pharmaceutical setting
Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
General knowledge of drug development
Proven track record of successful project management experience supporting early
- and late-stage and submission programs
Leadership skills, including experience leading multi-disciplinary project teams
Strong project management skills
Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally
Strong personal and leadership skills to influence without authority, motivate others and manage conflict
Strong communicator and team player
Strong working knowledge of MS Project, Smartsheet and timeline visualization software (i.e. One Pager, ThinkCell)
**Preferred**: Project/program management training
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
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 adop
