![CTC Resourcing Solutions](https://www.datacareer.ch/files/pictures/download_29.jpg)
Regulatory Cmc Manager
vor 1 Woche
The Life Science Career Network
Our 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 pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a role based inBasel for 18 months contract for a:
Regulatory Affairs CMC Manager
Main Responsibilities:
- Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products;
- Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines;
- Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and epublishing requirements;
- Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders;
- Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- A Life Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent;
- 5 years + working knowledge and experience in regulatory submission and approval processes;
- Experience working in chemistry/biotechnology, analytics or pharmaceutical technology;
- Demonstrated track record to successfully work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects.
-
Regulatory Affairs Manager Cmc
vor 1 Woche
Basel, Basel-Stadt, Schweiz Coopers Group AG VollzeitRegulatory Affairs Manager CMCFor our client in Basel, we are looking for RA CMC Manager who will be responsible for global CMC submission activities for assigned projects.Responsibilities: Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source...
-
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 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 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 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,...
-
Global Regulatory Cmc Lead
vor 1 Woche
Basel, Basel-Stadt, Schweiz Hobson Prior VollzeitHobson Prior are collaborating with a brilliant pharma establishment who are currently looking for an individual to join their team on a permanent basis located in either Basel or Stockholm. Our client is focused on offering novel remedies that will transform the lives of those suffering from rare illnesses. Th opening position is for a Global regulatory CMC...
-
Cmc Dossier Manager
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.CMC Dossier Manager:Role &...
-
Ra Cmc Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Hobson Prior VollzeitHobson Prior are looking for a RA CMC Manager to join a brilliant pharmaceutical corporation on a contract basis located in Basel. Our client is focused on improving and prolonging the lives of many.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities: For this position, you will be accountable...
-
Ra Cmc Associate Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitThe Life Science Career NetworkOur client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for an Regulatory Affairs CMC Manager for 18 month contract role based in Basel, Switzerland.As Associate Manager within our Global Regulatory Affairs CMC team, you support timely...
-
Cmc Dossier Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Sobi VollzeitCMC Dossier ManagerThe CMC Dossier Manager works in the Sobi Technical Operations Department within in the CMC Program Management unit. The role is responsible for technical oversight and the coordination of generation of CMC documentation. Within the scope is the source documentation for process development, process validation, GMP and non-GMP manufacture...
-
Vp, Global Cmc Regulatory Affairs
vor 1 Woche
Basel, Basel-Stadt, Schweiz Moderna VollzeitThe Role:Here's What You'll Do:Provide leadership for regulatory CMC aspects of product development projectsLead and drive all CMC submission activities (planning,Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelinesDevelop effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA)...
-
Associate Director, Cmc Regulatory Affairs
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,...
-
Regulatory Affairs Manager
vor 1 Woche
Basel, Basel-Stadt, 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 (IND/IMPD) and...
-
Ra Cmc Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Warman O'Brien VollzeitA Regulatory Affairs CMC Manager is required to join a global pharmaceutical company based in Basel on an 18-month contract.What you will be doing: Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or...
-
Head of Cmc
vor 1 Woche
Basel, Basel-Stadt, Schweiz Sobi VollzeitThe RoleAs Head of CMC, you will ensure that late development and lifecycle plan are translated in sustainable reality. For this, you can rely on a team of CMC project lead and CMC dossier managers. They manage end to end complex technical CMC projects, including budget and reporting, CMC regulatory strategy and scientific writing. You will work closely with...
-
Senior Manager – CMC Dossier Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Aixial Group VollzeitSenior Manager – CMC Dossier Manager (M/F) Location : Basel, Switzerland Who is Aixial Group ? Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market. Since 2014, we have been part of the Alten...
-
Head of Cmc Program Management
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.Head of CMC Program...
-
Cmc Technical Writer
vor 1 Woche
Basel, Basel-Stadt, Schweiz Aixial VollzeitWho is Aixial Group ?Aixial Group, we are a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.Since 2014, we have been part of the Alten family.We are developing our activities in Switzerland, France, Belgium, Czech Republic,...
-
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...
-
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...